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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90512

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

Open FDA event record

Event summary

Timeline bucket
June 30, 2022
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Nephron Sterile Compounding Center LLC

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

37 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 37

Amino Acid Injection 50 g/1000 mL (50 mg/mL) bags, Rx Only, Nephron 503B outsourcing facility, 4500 12th Extension, West Columbia, SC 29172, NDC: 69374-988-10

D-1245-2022
Recall number
D-1245-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
163 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

Lots: AA2012A, Exp. 07/04/2022

Distribution pattern

Nationwide in the USA

drug · product 2 of 37

Atropine Sulfate Injection, USP 1.2 mg/3 mL (0.4 mg/mL) syringe, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-935-03

D-1246-2022
Recall number
D-1246-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
13,340 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

Lots: AS2001A, Exp. 8/2/2022; AS2002A, Exp. 8/17/2022; AS2003A, Exp. 9/3/2022.

Distribution pattern

Nationwide in the USA

drug · product 3 of 37

0.125% Bupivacaine HCl Injection, USP, 62.5 mg/50 mL (1.25 mg/mL) syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Ext., West Columbia, SC 29172, NDC: 69374-970-50

D-1247-2022
Recall number
D-1247-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
6900 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

Lots: BH2001A, Exp. 7/15/2022; BH2002A, Exp. 8/7/2022; BH2004A, Exp. 8/22/2022; BH2005A, Exp. 9/2/2022; BH2006A, Exp. 9/14/2022; BH2007A, Exp. 9/29/2022; BH2008A, Exp. 10/3/2022; BH2010A, Exp. 10/19/2022

Distribution pattern

Nationwide in the USA

drug · product 4 of 37

0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate), 45 mg/5 mL (9 mg/mL) syringes, packaged in 5 x 5 mL Prefilled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-947-50

D-1248-2022
Recall number
D-1248-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
1380 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

Lots: BL2007A, Exp. 7/3/2022

Distribution pattern

Nationwide in the USA

drug · product 5 of 37

Bupivacaine HCl 150 mg (3.0 mg/mL), Ketorolac Tromethamine 60 mg (1.2 mg/mL), Ketamine HCl 60 mg (1.2 mg/mL) Injection, 50 mL syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-514-50

D-1249-2022
Recall number
D-1249-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
2315 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

Lots: BP2001A, Exp. 7/6/2022; BP2002A, Exp. 7/27/2022; BP2007A, Exp. 7/3/2022

Distribution pattern

Nationwide in the USA

drug · product 6 of 37

EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL) syringes, 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia SC 29172, NDC: 69374-544-10

D-1250-2022
Recall number
D-1250-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
19,060 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

Lots: EN2001A, Exp. 7/9/2022; EN2003A, Exp. 7/18/2022; EN2004A, Exp. 8/1/2022; EN2012A, Exp. 9/1/2022

Distribution pattern

Nationwide in the USA

drug · product 7 of 37

EPINEPHrine Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-925-10

D-1251-2022
Recall number
D-1251-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
134,385 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

Lots: EN2007A, Exp. 7/31/2022; EN2008A, Exp. 8/18/2022; EN2013A, Exp. 9/11/2022; EN2014A, Exp. 10/2/2022

Distribution pattern

Nationwide in the USA

drug · product 8 of 37

Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL*) bags, packaged as 10 x 1 IV bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-523-21

D-1252-2022
Recall number
D-1252-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
9410 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

Lots: FN2001A, Exp. 7/8/2022; FN2001B, Exp. 7/8/2022; FN2002A, Exp. 7/19/2022; FN2002B, Exp. 7/19/2022; FN2003A, Exp. 8/24/2022; FN2003B, Exp. 8/24/2022

Distribution pattern

Nationwide in the USA

drug · product 9 of 37

Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL) syringes, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-05

D-1253-2022
Recall number
D-1253-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
3690 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

Lots: GL2001A, Exp. 7/15/2022

Distribution pattern

Nationwide in the USA

drug · product 10 of 37

Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL) syringes, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-30

D-1254-2022
Recall number
D-1254-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
3450 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

Lot: GL2004A, Exp. 8/26/2022

Distribution pattern

Nationwide in the USA

drug · product 11 of 37

HYDROmorphone HCl Injection, USP, 10 mg/50 mL (0.2 mg/mL) syringes, 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia SC 29172, NDC: 69374-529-50

D-1255-2022
Recall number
D-1255-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
22,805 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

Lots: HH2002A, Exp. 7/7/2022; HH2004A, Exp. 8/28/2022; HH2005A, Exp. 8/11/2022; HH2007A, Exp. 9/2/2022; HH2009A, Exp. 9/10/2022; HH2011A, Exp. 10/17/2022

Distribution pattern

Nationwide in the USA

drug · product 12 of 37

HYDROmorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL) syringes, 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-529-30

D-1256-2022
Recall number
D-1256-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
12,900 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

Lots: HH2003A, Exp. 7/26/2022; HH2006A, Exp. 8/22/2022

Distribution pattern

Nationwide in the USA

drug · product 13 of 37

HYDROmorphone HCl Injection, USP 30 mg/30 mL (1 mg/mL) syringe, 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-30

D-1257-2022
Recall number
D-1257-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
18,570 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

Lots: HN2001A, Exp. 7/23/2022; HN2003A, Exp. 8/19/2022; HN2004A, Exp. 9/9/2022

Distribution pattern

Nationwide in the USA

drug · product 14 of 37

HYDROmorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL) syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-50

D-1258-2022
Recall number
D-1258-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
3740 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

Lot: HN2002A, Exp. 7/26/2022

Distribution pattern

Nationwide in the USA

drug · product 15 of 37

Ketamine HCl Injection, USP, 50 mg/5 mL (10 mg/mL*) syringes, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-55

D-1259-2022
Recall number
D-1259-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
91,445 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

Lots: KH2006A, Exp. 7/20/2022; KH2006B, Exp. 7/20/2022; KH2012B, Exp. 8/23/2022

Distribution pattern

Nationwide in the USA

drug · product 16 of 37

Ketamine HCl Injection, USP 30 mg/3 mL (10 mg/mL*) syringes, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-33

D-1260-2022
Recall number
D-1260-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
30,745 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

Lots: KH2002A, Exp. 7/5/2022

Distribution pattern

Nationwide in the USA

drug · product 17 of 37

Ketamine HCl Injection, USP, 50 mg/1 mL (50 mg/mL*) syringe, packaged in 5 x 1 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-511-01

D-1261-2022
Recall number
D-1261-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
47,905 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

Lots: KH2009A, Exp. 8/16/2022; KH2011A, Exp. 8/24/2022; KH2013A, Exp. 8/28/2022; KH2014A, Exp. 9/9/2022; KH2018A, Exp. 10/7/2022; KH2020A, Exp. 10/18/2022

Distribution pattern

Nationwide in the USA

drug · product 18 of 37

Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL) syringe, packaged in 5 x 4 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-946-04

D-1262-2022
Recall number
D-1262-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
184,370 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

Lots: LB2002A, Exp. 7/12/2022; LB2004A, Exp. 8/21/2022; LB2006A, Exp. 9/3/2022; LB2008A, Exp. 10/6/2022

Distribution pattern

Nationwide in the USA

drug · product 19 of 37

Lidocaine HCl Injection, USP 2%, 100 mg/5 mL (20 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-949-05

D-1263-2022
Recall number
D-1263-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
64,380 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

Lots: LI2007A, Exp. 9/24/2022

Distribution pattern

Nationwide in the USA

drug · product 20 of 37

Lidocaine HCl Injection, USP 1%, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-985-05

D-1264-2022
Recall number
D-1264-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
37,310 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

Lots: LI2004A, Exp. 8/6/2022; LI2005A, Exp. 8/31/2022; LI2006A, Exp. 9.21.2022; LI2008A, Exp. 10/11/2022

Distribution pattern

Nationwide in the USA

drug · product 21 of 37

Morphine Sulfate Injection, USP, 50 mg/50 mL (1 mg/mL) syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-50

D-1265-2022
Recall number
D-1265-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
5495 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

Lots: MS2002A, Exp. 7/2/2022; MS2003A, Exp. 7/30/2022; MS2005A, Exp. 7/31/2022; MS2008A, Exp. 8/23/2022; MS2013A, Exp. 9/9/2022; MS2015A, Exp. 9/26/2022; MS2019A, Exp. 10/14/2022

Distribution pattern

Nationwide in the USA

drug · product 22 of 37

Morphine Sulfate Injection, USP, 30 mg/30 mL (1 mg/mL) syringe, packaged in 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-30

D-1266-2022
Recall number
D-1266-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
8985 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

Lots: MS2004A, Exp. 7/30/2022; MS2007A, Exp. 8/23/2022; MS2012A, Exp. 9/6/2022; MS2014A, Exp. 9/10/2022; MS2016A, Exp. 9/29/2022; MS2018A, Exp. 10/12/2022

Distribution pattern

Nationwide in the USA

drug · product 23 of 37

Morphine Sulfate Injection, USP, 2 mg/2 mL (1 mg/mL) syringe, packaged in 5 x 2 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-02

D-1267-2022
Recall number
D-1267-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
43,385 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

Lots: MS2001A, Exp. 7/2/2022; MS2006A, Exp. 8/9/2022; MS2009A, Exp. 8/25/2022; MS2011A, Exp. 9/3/2022; MS2017A, Exp. 10/2/2022

Distribution pattern

Nationwide in the USA

drug · product 24 of 37

Morphine Sulfate Injection, USP, 1 mg/mL syringe, packaged in 5 x 1 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-01

D-1268-2022
Recall number
D-1268-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
4620 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

Lot: MS2010A, Exp. 8/26/2022

Distribution pattern

Nationwide in the USA

drug · product 25 of 37

del Nido Cardioplegia Solution 1000 mL (1000 mL) Single-Dose Container IV bag, 4 x 1 IV Bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-984-10

D-1269-2022
Recall number
D-1269-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
1765 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

Lots: NC2031A, Exp. 7/7/2022; NC2033A, Exp. 7/12/2022; NC2034A, Exp. 7/18/2022; NC2035A, Exp. 7/19/2022

Distribution pattern

Nationwide in the USA

drug · product 26 of 37

Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL) syringe, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-932-03

D-1270-2022
Recall number
D-1270-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
59,520 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

Lots:NE2002A, Exp. 7/14/2022; NE2003A, Exp. 7/24/2022; NE2006A, Exp. 8/1/2022; NE2007A, Exp. 8/9/2022; NE2008A, Exp. 8/18/2022; NE2009A, Exp. 8/27/2022; NE2012D, Exp. 10/3/2022

Distribution pattern

Nationwide in the USA

drug · product 27 of 37

Neostigmine Methylsulfate Injection, USP, 4 mg/4 mL (1 mg/mL) syringe, packaged in 5 x 4 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-942-04

D-1271-2022
Recall number
D-1271-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
10,700 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

Lots: NE2004A, Exp. 7/26/2022; NE2010A, Exp. 9/5/2022; NE2013A, Exp. 10/20/2022

Distribution pattern

Nationwide in the USA

drug · product 28 of 37

Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-902-05

D-1272-2022
Recall number
D-1272-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
64,365 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

Lots: NE2005A, Exp. 7/23/2022; NE2012A, Exp. 10/3/2022; NE2012B, Exp. 10/3/2022; NE2012C, Exp. 10/3/2022

Distribution pattern

Nationwide in the USA

drug · product 29 of 37

Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP IV bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-543-50

D-1273-2022
Recall number
D-1273-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
1810 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

Lots: OX2013C, Exp. 7/9/2022; OX2013E, Exp. 7/9/2022

Distribution pattern

Nationwide in the USA

drug · product 30 of 37

Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-955-10

D-1274-2022
Recall number
D-1274-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
75,630 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

Lots: PE2001A, Exp. 7/1/2022; PE2003A, Exp. 7/12/2022; PE2013A, Exp. 8/29/2022; PE2014A, Exp. 10/5/2022

Distribution pattern

Nationwide in the USA

drug · product 31 of 37

Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL)syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-956-10

D-1275-2022
Recall number
D-1275-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
18,930 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

Lots: PE2018A, Exp. 10/3/2022

Distribution pattern

Nationwide in the USA

drug · product 32 of 37

Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-957-10

D-1276-2022
Recall number
D-1276-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
464,265 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

Lots: PE2004A, Exp. 7/11/2022; PE2008A, Exp. 7/22/2022; PE2008B, Exp. 7/22/2022; PE2008C, Exp. 7/22/2022; PE2009A, Exp. 8/5/2022; PE2009B, Exp. 8/5/2022; PE2009C, Exp. 8/5/2022; PE2011B, Exp. 8/22/2022; PE2017C, Exp. 9/14/2022; PE2019B, Exp. 4/11/2023; PE2019C, Exp. 4/11/2023

Distribution pattern

Nationwide in the USA

drug · product 33 of 37

Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-924-05

D-1277-2022
Recall number
D-1277-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
6340 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

Lot: RC2003B, Exp. 8/28/2022

Distribution pattern

Nationwide in the USA

drug · product 34 of 37

Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg (0.0008 mg/mL), Ketorolac Tromethamine 15 mg (0.3 mg/mL) Injection, 50 mL syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-515-50

D-1278-2022
Recall number
D-1278-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
2210 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

Lots: RP2003A, Exp. 7/20/2022; RP2003B, Exp. 7/20/2022

Distribution pattern

Nationwide in the USA

drug · product 35 of 37

8.4% Sodium Bicarbonate Injection, USP, 4.2 g/50 mL (84 mg/mL) 1 mEq/mL syringe, packaged in 1 x 50 mL Pre-Filled Syringe per carton, 30 x 1 syringe carton per case, Rx Only Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-214-50

D-1279-2022
Recall number
D-1279-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
36,354 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

Lots: SB2001B, Exp. 1/2/2023; SB2001C, Exp. 1/2/2023; SB2003A, Exp. 2/14/2023; SB2003B, Exp. 2/14/2023; SB2003C, Exp. 2/14/2023; SB2004A, Exp. 3/1/2023; SB2004B, Exp. 3/1/2023; SB2004C, Exp. 3/1/2023; SB2005A, Exp. 3/8/2023; SB2007A, Exp. 3/22/2023; SB2007B, Exp. 3/22/2023; SB2008A, Exp. 3/29/2023; SB2008B, Exp. 3/29/2023; SB2009A, Exp. 4/5/2023; SB2009B, Exp. 4/5/2023

Distribution pattern

Nationwide in the USA

drug · product 36 of 37

Anticoagulant Sodium Citrate Solution, USP 4%, 200 mg/5 mL (40 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-906-05

D-1280-2022
Recall number
D-1280-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
85,300 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

Lots: SC2002A, Exp. 7/9/2022; SC2004A, Exp. 7/17/2022; SC2005A, Exp. 8/2/2022; SC2006A, Exp. 8/16/2022; SC2007A, Exp. 8/27/2022; SC2008A, Exp. 9/7/2022; SC2009A, Exp. 9/14/2022; SC2010A, Exp. 9/20/2022; SC2011A, Exp. 10/10/2022

Distribution pattern

Nationwide in the USA

drug · product 37 of 37

Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-919-10

D-1281-2022
Recall number
D-1281-2022
Initiated
June 30, 2022
Classification
Class II
Status
Terminated
Quantity
18,840 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

Lot: SU2014A, Exp. 7/2/2022

Distribution pattern

Nationwide in the USA

Field note

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