Home / Recalls / Glenmark Generics Inc., USA / D-182-2013

D-182-2013 Class III Terminated

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

Recall Details

Product Type
Drugs
Report Date
March 13, 2013
Initiation Date
February 13, 2013
Termination Date
October 9, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
591,972 bottles

Product Description

Montelukast Sodium Tablets, 10 mg (base), packaged in a) 30-count tablets per bottle (NDC 68462-392-30) and b) 90-count tablets per bottle (NDC 68462-392-90), Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430.

Reason for Recall

Chemical Contamination: The recall has been initiated based on multiple complaints received from pharmacists and consumers reporting that they detected an off-odor, described as moldy, musty or fishy in nature which has been identified as trace levels of Tribromoanisole (TBA) and Trichloroanisole (TCA).

Distribution Pattern

Nationwide

Code Information

02122956, 02123226, 02123269, 02123480, 02123481, 02122933, 02122955, 02123062, 02123075, 02123085, 02123114, 02123115, 02123124, 02123125, 02123189, 02123199, 02123205, 02123219, 02123253, 02123270, 02123289, 02123295, 02123320, 02123333, 02123343, 02123349, 02123411, 02123421, 02123431, Exp 09/14 and 10/14

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