Recalls / Class III
Class IIID-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
- Brand name
- Pravastatin Sodium
- Generic name
- Pravastatin Sodium
- Active ingredient
- Pravastatin Sodium
- Route
- Oral
- NDCs
- 68462-195, 68462-196, 68462-197, 68462-198
- FDA application
- ANDA077987
- Affected lot / code info
- 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
Why it was recalled
Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.
Recalling firm
- Firm
- Glenmark Generics Inc., USA
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 246,528 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-04-05
- FDA classified
- 2013-05-16
- Posted by FDA
- 2013-05-22
- Terminated
- 2014-10-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-330-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.