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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73960

88 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 20, 2016
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Pharmakon Pharmaceuticals, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

88 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 88

Phenylephrine 40 mcg/mL injection in 0.9% Sodium Chloride 10 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0011-72

D-1256-2016
Recall number
D-1256-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
2100 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 2 of 88

Bupivacaine 1mg/mL injection in 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0019-02

D-1257-2016
Recall number
D-1257-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
130 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 3 of 88

Fentanyl Citrate 2 mcg/mL/Ropivacaine HCI 0.2% injection in 0.9% Sodium Chloride, 100 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0029-01

D-1258-2016
Recall number
D-1258-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
150 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 4 of 88

Fentanyl Citrate 50 mcg/ml injection, 2mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0100-69

D-1259-2016
Recall number
D-1259-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
4050 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 5 of 88

Succinylcholine Chloride 20 mg/mL injection , 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0104-70

D-1260-2016
Recall number
D-1260-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
650 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 6 of 88

Ceftriaxone 1GM injection in Sterile Water, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0106-72

D-1261-2016
Recall number
D-1261-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
1575

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 7 of 88

Hydromorphone HCl 1mg/ml injection in 0.9% Sodium Chloride, 100 mL Cadd Cassette (grey), Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0114-48

D-1262-2016
Recall number
D-1262-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
12

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 8 of 88

Fentanyl Citrate injection, 50 mcg/mL, 50 mL lntravia IV Bag Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0118-41

D-1263-2016
Recall number
D-1263-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
200

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 9 of 88

Propofol1% 10mg/mL injection, 20 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0119-73

D-1264-2016
Recall number
D-1264-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
2580

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 10 of 88

Epinephrine 100mcg/mL injection in 0.9% Sodium Chloride 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0120-72

D-1265-2016
Recall number
D-1265-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
280

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 11 of 88

Epinephrine (PF) 10mcg/mL in 0.9% Sodium Chloride, 5ml syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0135-70

D-1266-2016
Recall number
D-1266-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
400

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 12 of 88

Midazolam (PF) 5mg/ml 25 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0138-67

D-1267-2016
Recall number
D-1267-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
40

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 13 of 88

Adenosine 1mg/ml (PF) in 0.9% Sodium Chloride (Total 90 mg/90 ml in 100 mL PAB Container); Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0146-47

D-1268-2016
Recall number
D-1268-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
12

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 14 of 88

Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride 100 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0148-48

D-1269-2016
Recall number
D-1269-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
95

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 15 of 88

Fentanyl Citrate 2mcg/mL & Bupivacaine 0.125% in 0.9% Sodium Chloride 150 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0171-01

D-1270-2016
Recall number
D-1270-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
105

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 16 of 88

Potassium Chloride 40 mEq Added to 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0173-02

D-1271-2016
Recall number
D-1271-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
40

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 17 of 88

Norepinephrine 16 mg added to 0.9% sodium Chloride, 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0174-02

D-1272-2016
Recall number
D-1272-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
24

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 18 of 88

Promethazine 6.25 mg added to 0.9% Sodium Chloride 50 mL in 100 mL B/Braun PAB bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0177-41

D-1273-2016
Recall number
D-1273-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
40

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 19 of 88

Methohexital (Brevital Sodium) 10 mg/mL,10 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0180-72

D-1274-2016
Recall number
D-1274-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
225

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 20 of 88

Promethazine 12.5mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0186-41

D-1275-2016
Recall number
D-1275-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
725

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 21 of 88

Promethazine 25 mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag, Rx, Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0187-41

D-1276-2016
Recall number
D-1276-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
485

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 22 of 88

Phenylephrine HCI 40mg/250 mL in 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0189-02

D-1277-2016
Recall number
D-1277-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
10

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 23 of 88

HYDROmorphone 1mg/mL in 0.9% Sodium Chloride 1 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0190-78

D-1278-2016
Recall number
D-1278-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
4500

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 24 of 88

Cefazolin 2GM added to 100 mL 0.9% Sodium Chloride bag Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0216-48

D-1279-2016
Recall number
D-1279-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
1083

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 25 of 88

Cefazolin 3GM Added to a 100 mL 0.9% Sodium Chloride Bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0223-48

D-1280-2016
Recall number
D-1280-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
18

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 26 of 88

Morphine Sulfate (PF) 0.5mg/mL in 0.9% Sodium Chloride 1mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0322-78

D-1281-2016
Recall number
D-1281-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
25

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 27 of 88

Magnesium Sulfate 50 GM in Lactated Ringers 500 mL bag; Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0407-03

D-1282-2016
Recall number
D-1282-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
72

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 28 of 88

Morphine Sulfate 1mg/mL in 0.9% Sodium Chloride 50 mL fill in a 50 mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0502-41

D-1283-2016
Recall number
D-1283-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
20

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 29 of 88

Hydromorphone HCI 0.2mg/mL in 0.9% Sodium Chloride 50 mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0504-41

D-1284-2016
Recall number
D-1284-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
10

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 30 of 88

Fentanyl Citrate 10mcg/mL in 0.9% Sodium Chloride, 50mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0505-41

D-1285-2016
Recall number
D-1285-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
5

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 31 of 88

Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride 25 mL in 30 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0521-67

D-1286-2016
Recall number
D-1286-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
20

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 32 of 88

Ketamine 50mg/mL in 0.9% Sodium Chloride 1mL fill in 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0603-78

D-1287-2016
Recall number
D-1287-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
200

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 33 of 88

Bupivacaine HCI 0.125% 50 mL fill in a 60 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0608-75

D-1288-2016
Recall number
D-1288-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
40

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 34 of 88

Cefazolin 2GM added to 5% Dextrose 50 mL USP, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0610-41

D-1289-2016
Recall number
D-1289-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
1450

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 35 of 88

Provocholine pre-diluted in 0.9% Sodium Chloride Set II syringes, 0.0625mg/mL,3 mL; 0.25 mg/mL 3mL; 1 mg/mL 3mL; 4 mg/mL 3mL; 16 mg/ml 3mL, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0674-80

D-1290-2016
Recall number
D-1290-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
142

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 36 of 88

Fentanyl Citrate 25mcg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0683-68

D-1291-2016
Recall number
D-1291-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
5

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 37 of 88

Hydromorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0684-68

D-1292-2016
Recall number
D-1292-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
20

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 38 of 88

HYDROmorphone HCI 0.2mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0702-68

D-1293-2016
Recall number
D-1293-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
100

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 39 of 88

Ketamine 100mg/mL 1mL fill 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0709-78

D-1294-2016
Recall number
D-1294-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
600

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 40 of 88

Oxytocin 30 Units added to 0.9% Sodium Chloride in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0735-03

D-1295-2016
Recall number
D-1295-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
384

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 41 of 88

Oxytocin 20 Units added to 0.9% Sodium Chloride in a 1000mL lntravia bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0740-04

D-1296-2016
Recall number
D-1296-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
1809

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 42 of 88

Oxytocin 10 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0764-03

D-1297-2016
Recall number
D-1297-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
72

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 43 of 88

Oxytocin 30 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0766-03

D-1298-2016
Recall number
D-1298-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
468

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 44 of 88

Oxytocin 20 Units added to Lactated Ringers in a 1000 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0769-04

D-1299-2016
Recall number
D-1299-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
384

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 45 of 88

Midazolam HCI1mg/mL in 0.9% Sodium Chloride 100 mL fill in a 150 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0796-48

D-1300-2016
Recall number
D-1300-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
45

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 46 of 88

Epinephrine HCI 5 mcg/mL in 0.9% Sodium Chloride, 10mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0800-72

D-1301-2016
Recall number
D-1301-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
1200

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 47 of 88

Magnesium Sulfate 1GM Added to 0.9% Sodium Chloride, 50 mL bag, Rx only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0803-41

D-1302-2016
Recall number
D-1302-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
10

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 48 of 88

Norepinephrine Bitartrate 8mg Added to 5% Dextrose 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0806-02

D-1303-2016
Recall number
D-1303-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
70

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 49 of 88

HYDROmorphone HCI 0.4mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0813-68

D-1304-2016
Recall number
D-1304-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
670

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 50 of 88

HYDROmorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD syringe;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0815-67

D-1305-2016
Recall number
D-1305-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
560

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 51 of 88

Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0819-02

D-1306-2016
Recall number
D-1306-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
50

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 52 of 88

Morphine Sulfate (Preserved) 2mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 ml BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0823-75

D-1307-2016
Recall number
D-1307-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
30

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 53 of 88

Fentanyl Citrate 2.5 mcg/mL & Bupivacaine 0.075% in 0.9% Sodium Chloride, 60 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0826-77

D-1308-2016
Recall number
D-1308-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
260

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 54 of 88

Diltiazem HCI 250 mg in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0853-02

D-1309-2016
Recall number
D-1309-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
10

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 55 of 88

Fentanyl Citrate 5 mcg/mL & Bupivacaine 0.06% in 0.9% Sodium Chloride, 60 mL BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0827-77

D-1310-2016
Recall number
D-1310-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
100

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 56 of 88

Norepinephrine Bitartrate 4 mg (16mcg/mL) added to 5% Dextrose, 250 mL bag;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0855-02

D-1311-2016
Recall number
D-1311-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
250

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 57 of 88

Hydromorphone HCI 1 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag IV USE ONLY, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060 , NDC 45183-0865-41

D-1312-2016
Recall number
D-1312-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
675

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 58 of 88

Atropine Sulfate 0.4mg/mL 2.5 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0867-71

D-1313-2016
Recall number
D-1313-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
400

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 59 of 88

Fentanyl Citrate 10 mcg/mL(PF) in 0.9% Sodium Chloride 100 mL fill bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0869-48

D-1314-2016
Recall number
D-1314-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
75

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 60 of 88

Morphine Sulfate 1 mg/mL in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0875-02

D-1315-2016
Recall number
D-1315-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
215

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 61 of 88

Morphine Sulfate 1mg/mL (Preserved) in 0.9% Sodium Chloride, 50 mL lntravia bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0876-41

D-1316-2016
Recall number
D-1316-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
300

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 62 of 88

Morphine Sulfate (PF) 1mg/mL in 0.9% Sodium Chloride, 50 mL lntravia Bag IV USE ONLY, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0877-41

D-1317-2016
Recall number
D-1317-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
45

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 63 of 88

Vancomycin HCL 1.25 GM added to 5% Dextrose in a 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0885-02

D-1318-2016
Recall number
D-1318-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
216

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 64 of 88

Fentanyl Citrate 2 mcg/mL & Bupivacaine HCL 0.125 % in 0.9% Sodium Chloride, 150 mL lntravia bag;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0905-48

D-1319-2016
Recall number
D-1319-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
870

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 65 of 88

Fentanyl Citrate 2mcg/mL & Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 100 mL bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 5183-0906-48

D-1320-2016
Recall number
D-1320-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
20

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 66 of 88

Bupivacaine HCI 0.125% in 0.9% Sodium Chloride, 250 mL lntravia bag, Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0909-02

D-1321-2016
Recall number
D-1321-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
55

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 67 of 88

Succinylcholine Chloride 20 mg/mL, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0920-72

D-1322-2016
Recall number
D-1322-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
2175

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 68 of 88

Ketamine 20 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0925-41

D-1323-2016
Recall number
D-1323-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
175

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 69 of 88

Phenylephrine HCI100mcg/mL in 0.9% sodium Chloride 10ml fill in a 10mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0927-72

D-1324-2016
Recall number
D-1324-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
2735

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 70 of 88

HYDROmorphone HCI 1mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0932-68

D-1325-2016
Recall number
D-1325-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
90

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 71 of 88

HYDROmorphone HCI 0.2 mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 mL Monoject Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0933-75

D-1326-2016
Recall number
D-1326-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
120

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 72 of 88

Phenylephrine HCI (PF) 100mcg/mL in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0934-70

D-1327-2016
Recall number
D-1327-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
800

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 73 of 88

Morphine Sulfate 5mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0935-67

D-1328-2016
Recall number
D-1328-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
340

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 74 of 88

Ketamine 2 mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0938-68

D-1329-2016
Recall number
D-1329-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
150

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 75 of 88

Ephedrine Sulfate 5 mg/ml in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0939-70

D-1330-2016
Recall number
D-1330-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
800

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 76 of 88

Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 500mL lntravia bag, Rx only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0942-03

D-1331-2016
Recall number
D-1331-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
129

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 77 of 88

Lidocaine 2%, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0946-70

D-1332-2016
Recall number
D-1332-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
50

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 78 of 88

Rocuronium 10 mg/mL, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0955-70

D-1333-2016
Recall number
D-1333-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
1925

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 79 of 88

Ondansetron 2mg/mL, 2 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0957-69

D-1334-2016
Recall number
D-1334-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
2300

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 80 of 88

Cefazolin 1GM in Sterile Water, 10 ml BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0960-72

D-1335-2016
Recall number
D-1335-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
1675

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 81 of 88

Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0961-72

D-1336-2016
Recall number
D-1336-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
2665

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 82 of 88

Fentanyl Citrate 50 mcg/mL, 5ml syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0964-70

D-1337-2016
Recall number
D-1337-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
1500

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 83 of 88

Midazolam HCI 1mg/mL in 0.9% Sodium Chloride ,2 mL fill in a 3 mL syringe; Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0966-69

D-1338-2016
Recall number
D-1338-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
2000

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 84 of 88

Rocuronium 10mg/ml 10ml fill in a 10ml BD syringe; Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0971-72

D-1339-2016
Recall number
D-1339-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
1200

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 85 of 88

Vecuronium 1mg/mL in Sterile Water ,10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0972-72

D-1340-2016
Recall number
D-1340-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
275

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 86 of 88

Midazolam HCl 1mg/mL in 0.9% Sodium Chloride, 50 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0989-41

D-1341-2016
Recall number
D-1341-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
10

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 87 of 88

Bupivacaine HCI 0.25% in 0.9% Sodium Chloride, 500 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0994-03

D-1343-2016
Recall number
D-1343-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
70

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

drug · product 88 of 88

Sufentanil Citrate 0.4mcg/mL & Bupivacaine 0.1% in 0.9% Sodium Chloride 250 mL Intravia Bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN, NDC 45183-0996-02

D-1344-2016
Recall number
D-1344-2016
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Quantity
595

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All Sterile Compounded Products within Expiry

Distribution pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

Field note

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