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).
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.
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-182-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 13, 2013
- FDA report date
- Mar 13, 2013
- Quantity
- 591,972 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Generics Inc., USA
Original FDA data
Every field from FDA enforcement report D-182-2013, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 64338
- Address
- 750 Corporate Dr
- 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
- Postal code
- 07430-2009
- Report date
- Mar 13, 2013
- Product type
- Drugs
- Recall number
- D-182-2013
- Classification
- Class III
- Recalling firm
- Glenmark Generics Inc., USA
- Product quantity
- 591,972 bottles
- Termination date
- Oct 9, 2014
- 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).
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 13, 2013
- Initial firm notification
- Letter
- Center classification date
- Mar 5, 2013