Home / Recalls / Glenmark Generics Inc., USA / D-1229-2014

D-1229-2014 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
April 16, 2014
Initiation Date
March 18, 2014
Termination Date
January 21, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2904 bottles

Product Description

Ranitidine Tablets USP, 150 mg, 500-count bottles, Rx only, Manufactured by: Shasun Pharmaceuticals Limited, Unit-II R.S. No 32 33 & 34, Shasun Road, Periyakalapet, Puducherry, - 605 014, India; Manufactured for: Glenmark Generics Inc, USA, Mahwah, NJ 07430, UPC 3 68462 24805 8, NDC 68462-248-05.

Reason for Recall

Presence of Foreign Tablets/Capsules: Recall is due to a pharmacist complaint of a "foreign material", identified as Metoprolol Tartrate Tablet USP 50 mg, found co-mingled in a bottle of Ranitidine Tablets USP 150 mg.

Distribution Pattern

Nationwide

Code Information

Lot 12AN118A, Exp 10/14

Other recalls by Glenmark Generics Inc., USA

  • 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)
  • D-1701-2012 Class II — NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufacture (July 6, 2012)