Reported May 22, 2013 · Terminated
Glenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90), Rx only, Manufactured by Glenmark…
Glenmark Generics Inc., USA
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Glenmark Generics Inc., USA · 750 Corporate Dr · Mahwah, NJ · 07430-2009
Is this the product you have?
- 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 forGlenmark Generics USA Mahwah, NJ 07430
- Lot codes and dates
21 of 21 products
Products covered by this recall # Product as published 1 Lot # 02121059 Exp 03/15 2 Lot # 02121484 Exp 04/15 3 Lot # 02121530 Exp 04/15 4 Lot# 02121665 Exp 05/15 5 Lot# 02121669 Exp 05/15 6 Lot# 02121689 Exp 05/15 7 Lot# 02121705 Exp 05/15 8 Lot# 02123434 Exp 10/15 9 Lot# 02123446 Exp 10/15 10 Lot# 02123633 Exp 11/15 11 Lot# 02123677 Exp 11/15 12 Lot# 02123685 Exp 11/15 13 Lot# 02123695 Exp 11/15 14 Lot# 02123823 Exp 11/15 15 Lot# 02123833 Exp 11/15 16 Lot# 02123836 Exp 11/15 17 Lot# 02123853 Exp 11/15 18 Lot# 02123859 Exp 11/15 19 Lot# 02130021 Exp 12/15 20 Lot# 02130059 Exp 12/15 - Amount recalled
- 246,528 bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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