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
1Lot # 02121059 Exp 03/15
2Lot # 02121484 Exp 04/15
3Lot # 02121530 Exp 04/15
4Lot# 02121665 Exp 05/15
5Lot# 02121669 Exp 05/15
6Lot# 02121689 Exp 05/15
7Lot# 02121705 Exp 05/15
8Lot# 02123434 Exp 10/15
9Lot# 02123446 Exp 10/15
10Lot# 02123633 Exp 11/15
11Lot# 02123677 Exp 11/15
12Lot# 02123685 Exp 11/15
13Lot# 02123695 Exp 11/15
14Lot# 02123823 Exp 11/15
15Lot# 02123833 Exp 11/15
16Lot# 02123836 Exp 11/15
17Lot# 02123853 Exp 11/15
18Lot# 02123859 Exp 11/15
19Lot# 02130021 Exp 12/15
20Lot# 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.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new seafood recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Oct 9, 2014 · Data as of Sep 19, 6:32 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.