Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: recalling drug products following an FDA inspection.
Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-119-10 UPC 3 16729 11910 8; b) 90-count bottle NDC 16729-119-15 UPC 3 16729 11915 3; c) 1,000-count bottle NDC 16729-119-17 UPC 3 16729 11917 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
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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