Home / Recalls / Glenmark Generics Inc., USA / D-1701-2012

D-1701-2012 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
October 3, 2012
Initiation Date
July 6, 2012
Termination Date
August 13, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
unknown

Product Description

NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430; NDC 68462-190-01.

Reason for Recall

Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.

Distribution Pattern

Nationwide

Code Information

Lot #: 02112930, 02112934, 02112941, Exp 09/14; 2112985, 02112986, 02113334, Exp 10/14; 02113360, 02113372, 02113420, 02113606, 02113663, 02113664, Exp 11/14.

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-330-2013 Class III — Glenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90), (April 5, 2013)
  • 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)