FDA Drug recall D-330-2013
Glenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bar…
- FDA Drug
- Class III
- terminated
- Published 2013-05-22
On 2013-05-22 the FDA classified a Class III recall of Glenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bar… by Glenmark Generics Usa, citing chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-330-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-04-05 |
| Published | 2013-05-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Glenmark Generics Usa |
| Distribution | US |
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
Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.
Identifiers
| ndc | 68462-195-90 |
|---|---|
| ndc | 68462-195-05 |
| ndc | 68462-196-90 |
| ndc | 68462-196-05 |
| ndc | 68462-197-90 |
| ndc | 68462-197-05 |
| ndc | 68462-198-90 |
| ndc | 68462-198-05 |
| code_info | Lot # 02121059 Exp 03/15 Lot # 02121484 Exp 04/15 Lot # 02121530 Exp 04/15 Lot# 02121665 Exp 05/15 Lot# 0…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 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-330-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.