Drug recall D-330-2013
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
Reason for recall
Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.
Lots and codes
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 details
- Recalling firm
- Glenmark Generics Inc., USA, Mahwah, NJ
- Quantity
- 246,528 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 5, 2013
- Terminated
- October 9, 2014
Related products
- Pravastatin Sodium – drug information
- NDC 68462-198 Pravastatin Sodium · Pravastatin Sodium 80 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-197 Pravastatin Sodium · Pravastatin Sodium 40 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-195 Pravastatin Sodium · Pravastatin Sodium 10 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-196 Pravastatin Sodium · Pravastatin Sodium 20 mg/1 · Glenmark Pharmaceuticals Inc., USA