Multi-event January 2016 FDA Recall Drug by Golden State Medical Supply Inc.

This Multi-event Class III drug recall was voluntarily initiated by Golden State Medical Supply Inc. on January 27, 2016 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0768-2016 TERMINATED D-0769-2016 TERMINATED D-0767-2016 TERMINATED D-0770-2016 TERMINATED

Recall Number: D-0768-2016

Reason for Recall
Failed Impurities/Degradation Specifications
Initiated
01-27-2016
Reported
03-16-2016
Quantity
74 100-count packages (7,400 tablets)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73152
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Golden State Medical Supply Inc.
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-28-2016
Product Description About Product Description
Full technical description of the product.
Atorvastatin Calcium 20 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-324-77

Batch or Lot Expiration Information

Lot# GS008856; Exp. 09/17
Lot# GS010268; Exp. 09/17
Lot# GS010600; Exp. 11/17

Recall Number: D-0769-2016

Reason for Recall
Failed Impurities/Degradation Specifications
Initiated
01-27-2016
Reported
03-16-2016
Quantity
172 100-count packages (17,200 tablets)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73152
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Golden State Medical Supply Inc.
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-28-2016
Product Description About Product Description
Full technical description of the product.
Atorvastatin Calcium 40 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-325-77

Batch or Lot Expiration Information

Lot# GS009075; Exp. 09/17
Lot# GS009763; Exp. 09/17
Lot# GS010178; Exp. 10/17

Recall Number: D-0767-2016

Reason for Recall
Failed Impurities/Degradation Specifications
Initiated
01-27-2016
Reported
03-16-2016
Quantity
222 100-count packages (22,000 tablets)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73152
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Golden State Medical Supply Inc.
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-28-2016
Product Description About Product Description
Full technical description of the product.
Atorvastatin Calcium 10 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-323-77

Batch or Lot Expiration Information

Lot# GS005602; Exp. 10/15
Lot# GS008855; Exp. 09/17
Lot# GS009074; Exp. 08/17
Lot# GS009393; Exp. 08/17
Lot# GS009760; Exp. 10/17
Lot# GS010599; Exp. 11/17

Recall Number: D-0770-2016

Reason for Recall
Failed Impurities/Degradation Specifications
Initiated
01-27-2016
Reported
03-16-2016
Quantity
168 100-count packages (16,800 tablets)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73152
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Golden State Medical Supply Inc.
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-28-2016
Product Description About Product Description
Full technical description of the product.
Atorvastatin Calcium 80 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-326-77

Batch or Lot Expiration Information

Lot# GS005603; Exp. 10/15
Lot# GS006691; Exp. 08/17
Lot# GS009073; Exp. 08/17
Lot# GS009395; Exp. 08/17
Lot# GS009764; Exp. 10/17