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04-12-2013, 06:21 PM #1
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- Merced, CA 95348-1422
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Recalled Montelukast Sodium Tablets, 10 mg (base), packaged in a) 30-ct, & 90 ct
Montelukast Sodium 10 mg tablets Recalled due to contamination
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)
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
RECALLING FIRMGlenmark Generics Inc., USA; Mahwah, NJ
REASON FOR RECALLChemical 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).
*Human Drug Product Recalls Pending Classification
FDA is conducting a pilot program seeking to expedite notifications of human drug product recalls to the public. In addition to the information about classified recalls found in the weekly Enforcement Report, the agency will include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. The information will be continue to be provided in a narrative format until FDA has decided upon the method to include it in the new Enforcement Report format. They will be reposted with their classification in the Enforcement Report once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.