Drug Enforcement D-182-2013

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).

Status

Terminated

Classification

Class III

Report Date

March 13, 2013

Termination Date

October 9, 2014

Product Information

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.
Product quantity
591,972 bottles
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).
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Glenmark Generics Inc., USA
Address
750 Corporate Dr, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-182-2013
Event ID
64338
Recall initiation date
February 13, 2013
Center classification date
March 5, 2013
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
More code info
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