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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74187

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

Open FDA event record

Event summary

Timeline bucket
May 17, 2016
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Well Care Compounding Pharmacy

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

51 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 51

17-0H PROGESTERONE 250MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-0978-2016
Recall number
D-0978-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 units (total all products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 04262016: 87@3, Exp. 07/26/2016; Lot #: 03102016:72@38 , Exp. 06/08/2016; Lot #: 12222015:88@23, Exp. 03/22/2016; Lot #: 02022016:73@27, Exp. 05/03/2016

Distribution pattern

NV

drug · product 2 of 51

ALPHA LIPOIC ACID 25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-0979-2016
Recall number
D-0979-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 01252016:40@31, Exp. 04/27/2016; Lot #: 03072016:78@19, Exp. 06/6/2016; Lot #: 02222016:71@35, Exp. 05/27/2016

Distribution pattern

NV

drug · product 3 of 51

ATROPINE SULFATE 0.5% Ophthalmic Drops, packaged in 5mL droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-0980-2016
Recall number
D-0980-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 03252016:11 @26, Exp. 05/07/2016; Lot #: 04042016:28 @39, Exp. 05/06/2016; Lot #: 02102016:00 @22, Exp. 03/24/2016; Lot #:02112016:08 @13, Exp. 03/16/2016

Distribution pattern

NV

drug · product 4 of 51

ESTRADIOL CYPIONATE 10 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-0981-2016
Recall number
D-0981-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 03302016:68@10, Exp.06/28/2016; Lot #: 03082016:83@38, Exp. 06/06/2016; Lot #:02172016:37@51, Exp. 5/17/2016; Lot #: 2102016:80@55, Exp.5/30/2016

Distribution pattern

NV

drug · product 5 of 51

ESTRADIOL VALERATE 10MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-0982-2016
Recall number
D-0982-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 02022016:85@22 , Exp.05/03/2016; Lot #: 02242016:50@16, Exp. 06/12/2016; Lot #:03102016:30@65, Exp. 06/12/2016; Lot #: 3172016:14@19, Exp. 06/15/2016; Lot #: 04122016:20@2 , Exp. 07/11/2016; Lot #: 04212016:84@1, Exp. 07/20/2016.

Distribution pattern

NV

drug · product 6 of 51

ESTRADIOL VALERATE 20MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-0983-2016
Recall number
D-0983-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 04112016:76@67, Exp.07/12/2016

Distribution pattern

NV

drug · product 7 of 51

ESTRADIOL VALERATE 40MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-0984-2016
Recall number
D-0984-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 02162016:85@45, Exp. 5/17/2016; Lot #:03092016:30@19, Exp. 06/07/2016; Lot #: 01282016:77@25, Exp.05/03/2016; Lot #: 3112016:98@21, Exp. 06/13/2016; Lot #:03242016:52@22, Exp. 06/27/2016; Lot #: 04122016:15@50, Exp. 7/11/2016

Distribution pattern

NV

drug · product 8 of 51

GENTAMICIN 15 MG/ML Ophthalmic Solution, Sterile Droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-0985-2016
Recall number
D-0985-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 01182016:29@27 , Exp. 02/01/2016; Lot #: 030720 1631@50, Exp. 03/21/2016; Lot #: 03232016:83@6, Exp 04/06/2016; Lot #: 03282016:43@11, Exp. 04/11/2016; Lot #: 04192016:43@16, Exp. 05/03/2016

Distribution pattern

NV

drug · product 9 of 51

GLUTATHIONE 100MG/ML, packaged in 10 mL vials, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-0986-2016
Recall number
D-0986-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 02222016:97@38, Exp.05/24/2016; Lot #: 03032016:27@26 , Exp. 06/26/2016; Lot #: 4272016:60@37, Exp. 07/26/2016; Lot #: 01132016:18@44, Exp. 02/03/2016; Lot #: 01132016:74 @17, Exp. 03/04/2016; Lot #: 01132016:90@9, Exp. 03/04/2016; Lot #: 02222016:34@23, Exp. 04/03/2016; Lot #: 04282016:79@45, Exp. 06/27/2016

Distribution pattern

NV

drug · product 10 of 51

GLUTATHIONE 200MG/ML, packaged in 5mL vials, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-0987-2016
Recall number
D-0987-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 02232016: 64@43, Exp. 05/24/2016; Lot #: 03142016: 70@16,Exp. 06/14/2016; Lot #: 04182016:17@15, Exp.07/17/2016; Lot #: 04182016:64@12, Exp. 07/18/2016.

Distribution pattern

NV

drug · product 11 of 51

1-HCG 1000 IU/ML, packaged in 5mL and 10mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-0988-2016
Recall number
D-0988-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 01072016: 23@28, Exp. 04/06/2016; Lot #: 01082016: 27@1, Exp. 04/07/2016; Lot #:02012016:20@39, Exp. 05/01/2016; Lot #: 02022016:07@7, Exp.05/02/2016; Lot #: 02152016:29@50, Exp. 05/15/2016; Lot #: 02292016: 40@24, Exp.05/29/2016; Lot #: 02292016: 12@42 , Exp.05/29/2016; Lot #: 03042016:96@9, Exp.06/02/2016; Lot #: 03082016:59@34, Exp.06/08/2016 03142016:65@58, Exp.06/12/2016; Lot #: 03212016: 66@2, Exp.06/19/2016; Lot #: 03022016:50@38, Exp.06/23/2016; Lot #: 03302016: 93@11, Exp. 06/28/2016; Lot #: 04062016:79@22, Exp.07/07/2016; Lot #: 04122016 38@58, Exp.07/12/2016; Lot #: 04152016: 87@1, Exp. 07/14/2016; Lot #: 04152016:12@12, Exp. 07/14/2016; Lot #: 04222016: 55@27, Exp.07/21/2016

Distribution pattern

NV

drug · product 12 of 51

1-HCG 2000 IU/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-0989-2016
Recall number
D-0989-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 032520164: 7@1, Exp 06/23/2016

Distribution pattern

NV

drug · product 13 of 51

HCG/METHYLCOBALAMIN/FOLIC ACID,1000IU/5MG/0.4MG/ML; packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-0990-2016
Recall number
D-0990-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 03012016:82@33, Exp. 05/30/2016; Lot #: 03012016:65@41, Exp. 06/16/2016; Lot #: 04142016:89@48, Exp. 07/12/2016; Lot #: 04142016: 28@49, Exp. 07/17/2016

Distribution pattern

NV

drug · product 14 of 51

Hydrogen Peroxide 3%, packaged in 10mL bottles, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-0991-2016
Recall number
D-0991-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 01222016:81@52, Exp. 03/25/2016; Lot #:03042016: 23@29, Exp.05/22/2016; Lot #:03212016:35@53, Exp. 05/22/2016

Distribution pattern

NV

drug · product 15 of 51

LEVOCARNITINE 100MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-0992-2016
Recall number
D-0992-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 03142016:25@14, Exp. 04/15/2016; Lot #: 04182016: 22@14, Exp. 05/18/2016; Lot #: 04182016: 67@16, Exp. 05/19/2016

Distribution pattern

NV

drug · product 16 of 51

L-GLUT/L-ARG/L-CARN; 25MG/100MG/200MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-0993-2016
Recall number
D-0993-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 01272016:54@25, Exp.02/27/2016; Lot #: 03292016: 62@36 , Exp.04/29/2016

Distribution pattern

NV

drug · product 17 of 51

M.l.C. 25MG/50MG/25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-0994-2016
Recall number
D-0994-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 01042016: 45@46, Exp. 07/02/2016; Lot #:01112016: 87@46, Exp. 07/10/2016; Lot #:01112016:78@63, Exp. 07/10/2016; Lot #: 01272016:81@30, Exp.07/25/2016; Lot #: 02102016:89@2, Exp. 08/08/2016; 02162016:25@57, Exp.08/14/2016; 02262016:33@54, Exp.08/24/2016; Lot #: 03092016:64@51, Exp.09/07/2016; Lot #: 04142016:01@45, Exp.10/11/2016 04142016:17@37, Exp.10/15/2016; 04282016:72@48, Exp.10/29/2016.

Distribution pattern

NV

drug · product 18 of 51

M.I.C. /MB12/B6/DEXPLAN/L-CARN, 25MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-0995-2016
Recall number
D-0995-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 01222016:57@21, Exp.03/33/2016; Lot #: 01222016: 78@51, Exp.04/25/2016; Lot #: 01272016:51@23, Exp. 03/27/2016; Lot #: 02292016:71@13, Exp. 04/29/2016; Lot #: 03022016:46@14, Exp. 06/22/2016; Lot #:04252016:20@62, Exp.06/24/2016; Lot #: 04262016:18@11, Exp.06/25/2016

Distribution pattern

NV

drug · product 19 of 51

M.l.C. Methyl B12, 25 MG/50MG/25MG/1 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-0996-2016
Recall number
D-0996-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 03222016:11@22, Exp. 09/20/2016

Distribution pattern

NV

drug · product 20 of 51

MB 12/HXB 12/FA/P5P/(LIDO 0.1 %), 2MG/2MCi/20MG/6.5MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-0997-2016
Recall number
D-0997-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 01182016:46@7, Exp.04/17/2016; Lot #: 02192016 60@29, Exp. 05/19/2016; Lot #: 04082016:83@53; Exp. 07/11/2016; Lot #: 04202016:61@66, Exp.07/19/2016.

Distribution pattern

NV

drug · product 21 of 51

M.l.C./B5/B6 25 MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-0998-2016
Recall number
D-0998-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 01272016:00@24, Exp.03/28/2016; Lot #: 03292016: 96@35, Exp. 05/24/2016

Distribution pattern

NV

drug · product 22 of 51

METHYLCOBALAMIN 12.5MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-0999-2016
Recall number
D-0999-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 02022016 : 72@19, Exp. 07/13/2016; Lot #: 02092016: 09@23, Exp. 08/08/2016; Lot #: 02262016:14@7, Exp. 08/27/2016; Lot #:03022016: 60@23, Exp. 08/21/2016; Lot #: 03012016:54@20, Exp.08/24/2016; Lot #: 03212016: 35@49, Exp. 09/17/2016; Lot #: 04142016: 15@2, Exp. 10/11/2016; Lot #: 04212016: 69@19, Exp.10/19/2016.

Distribution pattern

NV

drug · product 23 of 51

METHYLCOBALAMIN 1 MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-1000-2016
Recall number
D-1000-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 01062016: 32@16, Exp.04/06/2016; Lot #: 01252016: 96@51, Exp. 07/23/2016; Lot #: 03302016: 68@42, Exp. 09/25/2016; Lot #: 04042016:11@27, Exp.10/02/2016; Lot #: 04122016: 90@15, Exp. 10/09/2016 04202016:57@13, Exp.10/22/2016.

Distribution pattern

NV

drug · product 24 of 51

METHYLCOBALAMIN 5MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-1001-2016
Recall number
D-1001-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 01262016:77@53, Exp. 04/25/2016

Distribution pattern

NV

drug · product 25 of 51

METHYLCOBALAMIN/FOLIC ACID; 10MG/0.8MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-1002-2016
Recall number
D-1002-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 01262016:86@2, Exp. 07/30/2016; 02222016:31@27, Exp. 08/20/2016; Lot #: 03022016:1@47, Exp. 08/29/2016; Lot #: 03032016:26@ 1, Exp. 08/30/2016; Lot #: 04122016: 84@227, Exp.10/15/2016.

Distribution pattern

NV

drug · product 26 of 51

MYERS' COCKTAIL, packaged in 37 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-1003-2016
Recall number
D-1003-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 01112016:29@20, Exp. 01/19/2016; Lot #:01202016: 85@9, Exp. 01/27/2016; Lot #: 01222016: 56@17, Exp. 01/29/2016; Lot #: 01222016:36@49, Exp.02/02/2016; Lot #: 01262016:72@12, Exp.02/02/2016; Lot #: 01262016: 56@58, Exp.02/03/2016; Lot #: 02052016:89@26, Exp.03/02/2016; Lot #: 02112016:55@39, Exp.03/03/2016; Lot #: 02102016: 95@17, Exp. 03/08/2016; Lot #: 02222016:39@46, Exp. 03/15/2016; Lot #: 04222016:40@48, Exp.03/16/2016; Lot #: 02262016:53@13, Exp.03/24/2016; Lot #: 03072016: 01@14, Exp. 03/29/2016; Lot #: 03082016:40@11, Exp.03/30/2016; Lot #: 3012016:90@30, Exp.04/07/2016; Lot #: 03012016:78@13, Exp.04/18/2016; Lot #: 03222016: 19@17 04/13/2016; Lot #: 0331201661@40, Exp.04/21/2016; Lot #: 04132016:89@17, Exp. 05/06/2016; Lot #: 04272016:35@45, Exp. 05/20/2016; Lot #: 04292016:70@27, Exp.05/23/2016.

Distribution pattern

NV

drug · product 27 of 51

PHENYLEPHERINE 0.5%, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-1004-2016
Recall number
D-1004-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 01282016:60@3, Exp.04/28/2016; Lot #: 02242016: 90@20, Exp.05/24/2016; Lot #: 02222016:06@67, Exp. 05/24/2016; Lot #: 03082016:81@21, Exp.06/06/2016; Lot #: 03162016: 62@1, Exp. 06/14/2016.

Distribution pattern

NV

drug · product 28 of 51

PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID- 5%/4.75%, packaged in 10mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-1005-2016
Recall number
D-1005-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 01252016:44@43, Exp. 07/26/2016.

Distribution pattern

NV

drug · product 29 of 51

QUAD-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-1006-2016
Recall number
D-1006-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 01292016:04@9, Exp.07/27/2016; Lot #: 04082016: 84@17, Exp. 10/09/2016.

Distribution pattern

NV

drug · product 30 of 51

QUAD-MIX #2, packaged in 5mL vial, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-1007-2016
Recall number
D-1007-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 02172016:86@12, Exp.05/18/2016; Lot #: 04012016:22@4, Exp.06/30/2016

Distribution pattern

NV

drug · product 31 of 51

QUAD-MIX #4 (MOD), packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-1008-2016
Recall number
D-1008-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 02052016:96@38, Exp.05/09/2016; Lot #: 04052016: 39@6, Exp. 07/04/2016; Lot #: 04132016:79@19, Lot #: 07/13/2016.

Distribution pattern

NV

drug · product 32 of 51

SUPER TRI-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-1009-2016
Recall number
D-1009-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 01062016:29@49, Exp.04/06/2016; Lot #: 02032016: 30@5, Exp.05/03/2016; Lot #: 03312016:91@17; Exp. 06/29/2016; Lot #: 03302016:17@40, Exp. 06/30/2016; Lot 4132016:46@20, Exp. 07/12/2016.

Distribution pattern

NV

drug · product 33 of 51

SUPER TRI-MIX #4, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-1010-2016
Recall number
D-1010-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 03022016:16@45, Exp. 06/01/2016.

Distribution pattern

NV

drug · product 34 of 51

TESTOSTERONE CYPIONATE 100MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-1011-2016
Recall number
D-1011-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 02042016: 80@58, Exp.05/04/2016; Lot #: 02222016:88@11, Exp.05/23/2016; Lot #: 03282016:42@5, Exp. 06/26/2016; Lot #: 03292016:29@1, Exp.06/27/2016; Lot #: 03222016:22@19, Exp. 06/28/2016; Lot #: 04202016:46@30, Exp.07/19/2016.

Distribution pattern

NV

drug · product 35 of 51

TESTOSTERONE CYPIONATE 10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-1012-2016
Recall number
D-1012-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 02032016: 60@27, Exp. 05/03/2016; Lot #: 02222016: 29@62, Exp. 05/22/2016; Lot #: 03072016:87@66, Exp.06/06/2016; Lot #: 4152016:34@39, Exp. 07/18/2016; Lot #: 04282016:06@14, Exp. 07/27/2016.

Distribution pattern

NV

drug · product 36 of 51

TESTOSTERONE CYPIONATE 150MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-1013-2016
Recall number
D-1013-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 01042016:26@3, Exp.04/03/2016; Lot #: 01072016: 10@15, Exp.04/06/2016; Lot #: 02032016:41@16, Exp. 05/03/2016; Lot #: 03152016: 62@44, Exp.06/15/2016; Lot #: 04292016:35@11, Exp. 07/31/2016.

Distribution pattern

NV

drug · product 37 of 51

TESTOSTERONE CYPIONATE 175MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-1014-2016
Recall number
D-1014-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 02172016:12@37, Exp. 05/18/2016; Lot #: 03182016: 88@13, Exp. 06/16/2016; Lot #: 04202016:35@14, Exp. 07/19/2016.

Distribution pattern

NV

drug · product 38 of 51

TESTOSTERONE CYPIONATE 200MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV

D-1015-2016
Recall number
D-1015-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 01142016:19@26, Exp. 04/14/2016; Lot #: 02032016:23@32, Exp. 05/05/2016, Lot #: 02092016:17@9, Exp.06/10/2016; Lot #: 04262016: 11@16, Exp. 07/27/2016; Lot #: 01112016:65@70, Exp.04/10/2016; Lot #: 01202016:57@46, Exp.04/19/2016; 01212016:08@34, Exp. 04/28/2016; Lot: 02082016:08@27, Exp.05/08/2016; Lot #: 02222016:82@50, Exp.05/22/2016 03142016:75@24, Exp. 06/14/2016; Lot #: 03212016:07@73, Exp. 06/26/2016 03232016:47@23, Exp. 06/28/2016; Lot #: 04062016:96@28, Exp. 07/06/2016 04132016:@46 , Exp. 07/13/2016; Lot #: 04192016:92@1, Exp.07/19/2016 04272016:63@11, Exp.07/26/2016.

Distribution pattern

NV

drug · product 39 of 51

TRI-MIX # 1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-1016-2016
Recall number
D-1016-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 02292016:67@10, Exp. 05/29/2016; Lot #: 03022016: 98@43, Exp.05/31/2016; Lot #: 03162016:25@32, Exp. 06/14/2016; Lot #: 03302016:36@36, Exp.06/30/2016

Distribution pattern

NV

drug · product 40 of 51

TRI-MIX # 2, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-1017-2016
Recall number
D-1017-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 11162016:19@6, Exp.02/15/2016.

Distribution pattern

NV

drug · product 41 of 51

TRI-MIX # 3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-1018-2016
Recall number
D-1018-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 02162016:54@17, Exp. 05/17/2016; Lot #: 03232016: 19@8, Exp. 06/20/2016.

Distribution pattern

NV

drug · product 42 of 51

TRI-MIX # 4, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-1019-2016
Recall number
D-1019-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 03022016:16@45, Exp. 06/01/2016

Distribution pattern

NV

drug · product 43 of 51

TRI-MIX # 5, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-1020-2016
Recall number
D-1020-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 12302015:53@18, Exp.04/29/2016; Lot #: 03142016:67@53, Exp. 06/12/2016; Lot #: 03302016: 43@38, Exp. 06/28/2016; Lot #: 03/292016: 30@23, Exp. 06/29/2016.

Distribution pattern

NV

drug · product 44 of 51

TRI-MIX # 6, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-1021-2016
Recall number
D-1021-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 01072016:16@30, Exp. 04/06/2016; Lot #: 01132016 : 34@42, Exp. 04/12/2016; Lot #: 03082016:02@13, Exp. 06/06/2016; Lot #: 03302016: 46@39, Exp. 06/30/2016

Distribution pattern

NV

drug · product 45 of 51

VANCOMYCIN 50MG/ML OPHTH SOLUTION; packaged in 10mL vial, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-1022-2016
Recall number
D-1022-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 01182016:09@28, Exp. 02/01/2016; Lot #: 03072016:50@49, Exp. 03/21/2016; Lot #: 03232016: 79@7, Exp. 04/06/2016; Lot #:03282016:15@10, Exp. 04/11/2016; Lot #: 04192016:35@14, Exp.07/19/2016.

Distribution pattern

NV

drug · product 46 of 51

VITAMIN B COMPLEX # 1; packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-1023-2016
Recall number
D-1023-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 01120J67: 6@22, Exp. 04/12/2016; Lot #: 021820J6 : 52@39, Exp.04/18/2016; Lot #: 02262016: 89@3, Exp. 04/26/2016; Lot #: 03082016 : 76@46 06/06/2016;03022016:61@8, Exp. 06/08/2016; 032120 16:49@65, Exp.06/21/2016; 01152016:48@14, Exp. 04/19/2016; 03032016:74@52, Exp. 05/02/2016; 03242016:68@13, Exp. 06/27/2016; 04142016:00@50, Exp. 06/13/2016.

Distribution pattern

NV

drug · product 47 of 51

VITAMIN B COMPLEX # 3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-1024-2016
Recall number
D-1024-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 01052016:13@44, Exp.03/07/2016; Lot #: 01052016: 06@43, Exp. 04/13/2016; Lot #: 04052016:84@24; Exp. 06/06/2016.

Distribution pattern

NV

drug · product 48 of 51

QUAD-MIX #3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-1025-2016
Recall number
D-1025-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
869 Units (Total All Products)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 011520J6:90@35, Exp.04/17/2016; Lot #: 04282016:23@31, Exp.08/01/2016.

Distribution pattern

NV

drug · product 49 of 51

CLOTRIMAZOLE 1%/ BETAMETHASONE DIPROPIONATE 0.05% OTIC SOLUTION, 15mL dropper, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-1026-2016
Recall number
D-1026-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
916 total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #:01082016:75@3, Exp.07/06/2016; Lot #:01282016:72@10, Exp. 07/27/2016; Lot #: 02012016:74@35, Exp. 07/31/2016; Lot #:02102016:40@16, Exp.08/09/2016; Lot #: 02242016:73@41, Exp. 08/23/2016; Lot #: 03102016:64@53, Exp.09/07/2016; Lot #:04052016:70@16 Exp. 10/02/2016; Lot #: 04222016:85@37, Exp.10/22/2016.

Distribution pattern

NV

drug · product 50 of 51

ITRACONAZOLE 0.2%/MUPIROCIN 0.2% NASAL SPRAY; 30 mL Spray, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-1027-2016
Recall number
D-1027-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
916 total units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 01042016:74@36, Exp. 07/03/2016; Lot #: 01052016:14@12, Exp.06/18/2016; Lot #: 01272016:70@17, Exp. 07/25/2016; Lot #:02222016:62@12, Exp.08/24/2016; Lot #:03212016:57@30, Exp. 09/17/2016; Lot #: 04182016:42@44, Exp.10/16/2016; Lot #:05012016:18@29, Exp.11/01/2016.

Distribution pattern

NV

drug · product 51 of 51

ITRACONAZOLE 0.2%/MUPIROCIN 0.2%/TRIAMCINOLONE 0.03% NASAL SPRAY, 15mL bottle, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-1028-2016
Recall number
D-1028-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Quantity
916 total units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information

Lot #: 02102016:22@57, Exp. 08/08/2016; Lot #: 02292016:59@55 ,Exp. 08/28/2016; Lot #: 03072016:68@7, Exp. 09/03/2016; Lot #: 4052016:41@56, Exp. 10/04/2016; Lot #: 04192016:41@34, Exp.10/16/2016.

Distribution pattern

NV

Field note

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