Reported Mar 13, 2013 · Terminated
Montelukast Sodium Tablets, 10 mg (base), packaged in a) 30-count tablets per bottle (NDC 68462-392-30) and b) 90-count…
Glenmark Generics Inc., USA
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Glenmark Generics Inc., USA · 750 Corporate Dr · Mahwah, NJ · 07430-2009
Is this the product you have?
- 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 byGlenmark Generics Ltd., Colvale-Bardez, Goa 403513, India
- Manufactured forGlenmark Generics Inc., USA, Mahwah, NJ 07430
- Lot codes and dates
0212295602123226021232690212348002123481021229330212295502123062021230750212308502123114021231150212312402123125021231890212319902123205021232190212325302123270021232890212329502123320021233330212334302123349021234110212342102123431Exp 09/14 and 10/14
- Amount recalled
- 591,972 bottles
Where it was sold
- Nationwide
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).
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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