Multi-event April 2013 FDA Recall Topiramate by Glenmark Generics Inc., Usa
This Multi-event Class III drug recall was voluntarily initiated by Glenmark Generics Inc., Usa on April 5, 2013 for the product Topiramate. The FDA reported the reason for recall as chemical contamination. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-330-2013
Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.
04-05-2013
05-22-2013
246,528 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Glenmark Generics Inc., USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
10-09-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Glenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for :Glenmark Generics USA Mahwah, NJ 07430
Batch or Lot Expiration Information
Lot# 02121059 Exp 03/15
Lot# 02121484 Exp 04/15
Lot# 02121530 Exp 04/15
Lot# 02121665 Exp 05/15
Lot# 02121669 Exp 05/15
Lot# 02121689 Exp 05/15
Lot# 02121705 Exp 05/15
Lot# 02123434 Exp 10/15
Lot# 02123446 Exp 10/15
Lot# 02123633 Exp 11/15
Lot# 02123677 Exp 11/15
Lot# 02123685 Exp 11/15
Lot# 02123695 Exp 11/15
Lot# 02123823 Exp 11/15
Lot# 02123833 Exp 11/15
Lot# 02123836 Exp 11/15
Lot# 02123853 Exp 11/15
Lot# 02123859 Exp 11/15
Lot# 02130021 Exp 12/15
Lot# 02130059 Exp 12/15
Lot# 02130079 Exp 12/15
Recall Number: D-329-2013
Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature.
04-05-2013
05-22-2013
a) 33,138 bottles (500ct) ; b)19,278 bottles (500 ct)
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Glenmark Generics Inc., USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
10-09-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Glenmark Gabapentin Tablets, a) 600mg, 500- count bottle (NDC 68462-126-05), b) 800 mg, 500- count bottle (NDC 68462-127-05), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India, Manufactured for : Glenmark Generics USA Mahwah, NJ 07430.
Batch or Lot Expiration Information
Lot# a) 600mg:
Lot# 02123419, Exp 10/14
Lot# 02123424, Exp 10/14
Lot# 02123430, Exp 10/14
Lot# 02123492, Exp 10/14
Lot# 02123523, Exp 10/14
Lot# 02123527, Exp 10/14
Lot# 02123532, Exp 10/14
Lot# 02123542, Exp 10/14
Lot# 02123546, Exp 10/14
Lot# 02123551, Exp 10/14
Lot# 02123555, Exp 10/14
Lot# 02123560, Exp 11/14
Lot# 02123566, Exp 11/14
Lot# 02123569, Exp 11/14 b) 800 mg
Lot# 02123440 Exp 10/14
Lot# 02123445 Exp 10/14
Lot# 02123454 Exp 10/14
Lot# 02123465 Exp 10/14
Lot# 02123789 Exp 11/14
Lot# 02123804 Exp 11/14
Lot# 02123821 Exp 11/14
Lot# 02123829 Exp 11/14
Lot# 02123834 Exp 11/14
Lot# 02123841 Exp 11/14
Lot# 02123845 Exp 11/14
Affected Packages Involved in this Recall
Recall Number: D-331-2013
Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature.
04-05-2013
05-22-2013
9624 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Glenmark Generics Inc., USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
10-09-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Glenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for : Glenmark Generics USA Mahwah, NJ 07430
Batch or Lot Expiration Information
Lot# 02123782, Exp 11/14
