Glenmark Pravastatin Sodium Tablets — Class III drug recall D-330-2013
Terminated recall by Glenmark Generics Inc., USA, reported 2013-05-22, distributed nationwide. Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor d
| Recall number | D-330-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Generics Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2013-04-05 |
| Classified | 2013-05-16 |
| Reported by FDA | 2013-05-22 |
| Terminated | 2014-10-09 |
| Distributed | Nationwide (US) |
| Quantity | 246,528 bottles |
| Reason classes | chemical contamination |
| NDC | 68462-0195, 68462-0195-05, 68462-0195-90, 68462-0196, 68462-0196-05, 68462-0196-90, 68462-0197, 68462-0197-05, 68462-0197-90, 68462-0198, 68462-0198-05, 68462-0198-90 |
| Lot numbers | 02121059, 02121484, 02121530, 02121665, 02121669, 02121689, 02121705, 02123434, 02123446, 02123633, 02123677, 02123685, 02123695, 02123823, 02123833, 02123836, 02123853, 02123859, 02130021, 02130059, 02130079, 03/15, 04/15, 05/15, 10/15, 11/15, 12/15 |
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.