Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup: MONTELUKAST SODIUM, CHEW Tablet, 4 mg may be potentially mislabeled as the following drug: DICYCLOMINE HCL, Tablet, 20 mg, NDC 00591079501, Pedigree: AD76639_4, EXP: 5/31/2014.
MONTELUKAST SODIUM, CHEW Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00006071131.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25…
Reason CGMP deviations.
Reason Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Reason cGMP deviations
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