Multi-event May 2016 FDA Recall Drug by Well Care Compounding Pharmacy

This Multi-event Class II drug recall was voluntarily initiated by Well Care Compounding Pharmacy on May 17, 2016 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in NV and the recall is currently terminated.

Reported Recall Events

D-1009-2016 TERMINATED D-1019-2016 TERMINATED D-0998-2016 TERMINATED D-1006-2016 TERMINATED D-0980-2016 TERMINATED D-1003-2016 TERMINATED D-0989-2016 TERMINATED D-0988-2016 TERMINATED D-1015-2016 TERMINATED D-0983-2016 TERMINATED D-0981-2016 TERMINATED D-0979-2016 TERMINATED D-1024-2016 TERMINATED D-1022-2016 TERMINATED D-1000-2016 TERMINATED D-1005-2016 TERMINATED D-1017-2016 TERMINATED D-1007-2016 TERMINATED D-0984-2016 TERMINATED D-0990-2016 TERMINATED D-0995-2016 TERMINATED D-1021-2016 TERMINATED D-0996-2016 TERMINATED D-1028-2016 TERMINATED D-1008-2016 TERMINATED D-1014-2016 TERMINATED D-1010-2016 TERMINATED D-1023-2016 TERMINATED D-1002-2016 TERMINATED D-0985-2016 TERMINATED D-0978-2016 TERMINATED D-1026-2016 TERMINATED D-0991-2016 TERMINATED D-1012-2016 TERMINATED D-0999-2016 TERMINATED D-1016-2016 TERMINATED D-1004-2016 TERMINATED D-1025-2016 TERMINATED D-1027-2016 TERMINATED D-1001-2016 TERMINATED D-0992-2016 TERMINATED D-0997-2016 TERMINATED D-1011-2016 TERMINATED D-0986-2016 TERMINATED D-0993-2016 TERMINATED D-0987-2016 TERMINATED D-0994-2016 TERMINATED D-0982-2016 TERMINATED D-1018-2016 TERMINATED D-1013-2016 TERMINATED D-1020-2016 TERMINATED

Recall Number: D-1009-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
SUPER TRI-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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.

Recall Number: D-1019-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
TRI-MIX # 4, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration Information

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

Recall Number: D-0998-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

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

Recall Number: D-1006-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
QUAD-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration Information

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

Recall Number: D-0980-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
ATROPINE SULFATE 0.5% Ophthalmic Drops, packaged in 5mL droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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

Recall Number: D-1003-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
MYERS' COCKTAIL, packaged in 37 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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.

Recall Number: D-0989-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
1-HCG 2000 IU/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration Information

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

Recall Number: D-0988-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
1-HCG 1000 IU/ML, packaged in 5mL and 10mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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

Recall Number: D-1015-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
TESTOSTERONE CYPIONATE 200MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV

Batch or Lot Expiration 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.

Recall Number: D-0983-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
ESTRADIOL VALERATE 20MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration Information

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

Recall Number: D-0981-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
ESTRADIOL CYPIONATE 10 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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

Recall Number: D-0979-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
ALPHA LIPOIC ACID 25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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

Recall Number: D-1024-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
VITAMIN B COMPLEX # 3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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.

Recall Number: D-1022-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
VANCOMYCIN 50MG/ML OPHTH SOLUTION; packaged in 10mL vial, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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.

Recall Number: D-1000-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
METHYLCOBALAMIN 1 MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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.

Recall Number: D-1005-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID- 5%/4.75%, packaged in 10mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration Information

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

Recall Number: D-1017-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
TRI-MIX # 2, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration Information

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

Recall Number: D-1007-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
QUAD-MIX #2, packaged in 5mL vial, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration Information

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

Recall Number: D-0984-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
ESTRADIOL VALERATE 40MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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

Recall Number: D-0990-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
HCG/METHYLCOBALAMIN/FOLIC ACID,1000IU/5MG/0.4MG/ML; packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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

Recall Number: D-0995-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration 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

Recall Number: D-1021-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
TRI-MIX # 6, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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

Recall Number: D-0996-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

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

Recall Number: D-1028-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
916 total units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
ITRACONAZOLE 0.2%/MUPIROCIN 0.2%/TRIAMCINOLONE 0.03% NASAL SPRAY, 15mL bottle, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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.

Recall Number: D-1008-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
QUAD-MIX #4 (MOD), packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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.

Recall Number: D-1014-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
TESTOSTERONE CYPIONATE 175MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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.

Recall Number: D-1010-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
SUPER TRI-MIX #4, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration Information

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

Recall Number: D-1023-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
VITAMIN B COMPLEX # 1; packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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.

Recall Number: D-1002-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
METHYLCOBALAMIN/FOLIC ACID; 10MG/0.8MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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.

Recall Number: D-0985-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
GENTAMICIN 15 MG/ML Ophthalmic Solution, Sterile Droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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

Recall Number: D-0978-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 units (total all products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
17-0H PROGESTERONE 250MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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

Recall Number: D-1026-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
916 total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
CLOTRIMAZOLE 1%/ BETAMETHASONE DIPROPIONATE 0.05% OTIC SOLUTION, 15mL dropper, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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.

Recall Number: D-0991-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
Hydrogen Peroxide 3%, packaged in 10mL bottles, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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

Recall Number: D-1012-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
TESTOSTERONE CYPIONATE 10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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.

Recall Number: D-0999-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
METHYLCOBALAMIN 12.5MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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.

Recall Number: D-1016-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
TRI-MIX # 1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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

Recall Number: D-1004-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
PHENYLEPHERINE 0.5%, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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.

Recall Number: D-1025-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
QUAD-MIX #3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration Information

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

Recall Number: D-1027-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
916 total units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
ITRACONAZOLE 0.2%/MUPIROCIN 0.2% NASAL SPRAY; 30 mL Spray, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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.

Recall Number: D-1001-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
METHYLCOBALAMIN 5MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration Information

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

Recall Number: D-0992-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
LEVOCARNITINE 100MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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

Recall Number: D-0997-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration 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.

Recall Number: D-1011-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
TESTOSTERONE CYPIONATE 100MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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.

Recall Number: D-0986-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
GLUTATHIONE 100MG/ML, packaged in 10 mL vials, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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

Recall Number: D-0993-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
L-GLUT/L-ARG/L-CARN; 25MG/100MG/200MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration Information

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

Recall Number: D-0987-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
GLUTATHIONE 200MG/ML, packaged in 5mL vials, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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.

Recall Number: D-0994-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
M.l.C. 25MG/50MG/25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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.

Recall Number: D-0982-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
ESTRADIOL VALERATE 10MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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.

Recall Number: D-1018-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
TRI-MIX # 3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration Information

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

Recall Number: D-1013-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
TESTOSTERONE CYPIONATE 150MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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.

Recall Number: D-1020-2016

Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Initiated
05-17-2016
Reported
06-15-2016
Quantity
869 Units (Total All Products)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74187
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Well Care Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
TRI-MIX # 5, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Batch or Lot Expiration 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.