← Search recalls
FDA (Drug enforcement)Recalled 2013-04-05closedclass iii

Glenmark Generics Inc., USA: 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 Manufactur

Is my product affected?

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 PRAVASTATIN SODIUM

Check against the official notice below — it lists the full affected range.

What happened

Glenmark Generics Inc. is recalling Pravastatin Sodium Tablets 40 mg in 90-count bottles nationwide due to chemical contamination. The recalled medication has an off-odor described as moldy, musty, or fishy. The recall affects 246,528 bottles across multiple lot numbers with expiration dates ranging from March 2015 through December 2015.

The source document does not specify a remedy or the actions affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.

Details from the source

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. Distribution: Nationwide Quantity: 246,528 bottles 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

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

All FDA (Drug enforcement) recalls

Hurt by this product? Start a free Case Check

ProductRisk is not a law firm and does not provide legal services or legal advice. ProductRisk is a free consumer product-safety information service operated by Plaintify, Inc., a technology company. If you ask to be connected with a law firm, any legal services are provided by that firm — not by ProductRisk or Plaintify.

Privacy · Plaintify