Recalls / Class III

Class IIID-182-2013

Product

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.

Affected lot / code info

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

Why it was recalled

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).

Recalling firm

Firm

Glenmark Generics Inc., USA

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009

Distribution

Quantity

591,972 bottles

Distribution pattern

Nationwide

Timeline

Recall initiated

2013-02-13

FDA classified

2013-03-05

Posted by FDA

2013-03-13

Terminated

2014-10-09

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-182-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.