Product Detail
Product Description
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

Recall Number D-330-2013

Classification Class III

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

Product Distributed Qty 246,528 bottles

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

Event Detail

Event Id 64995

Product Type Drugs

Status Ongoing


Recalling Firm Glenmark Generics Inc., USA, Mahwah, NJ, USA

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-04-05

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern Nationwide