Home / Recalls / Glenmark Generics Inc., USA / D-330-2013

D-330-2013 Class III Terminated

Recalled by Glenmark Generics Inc., USA — Mahwah, NJ

Recall Details

Product Type
Drugs
Report Date
May 22, 2013
Initiation Date
April 5, 2013
Termination Date
October 9, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
246,528 bottles

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

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 Pattern

Nationwide

Code Information

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

Other recalls by Glenmark Generics Inc., USA

  • D-1229-2014 Class II — Ranitidine Tablets USP, 150 mg, 500-count bottles, Rx only, Manufactured by: Sha (March 18, 2014)
  • D-329-2013 Class III — Glenmark Gabapentin Tablets, a) 600mg, 500- count bottle (NDC 68462-126-05), b (April 5, 2013)
  • D-331-2013 Class III — Glenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx on (April 5, 2013)
  • D-182-2013 Class III — Montelukast Sodium Tablets, 10 mg (base), packaged in a) 30-count tablets per bo (February 13, 2013)
  • D-1701-2012 Class II — NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufacture (July 6, 2012)