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Class II Recall
Apotex Corp.
Product
Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3
Reason
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Classification
Class II
Status
Ongoing
Lot
Lot # TY9494, Exp Date: 05/31/2027.
Date
2026-09-02
Disclaimer:
This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Apotex Corp. — Class II Recall | MedicineWatch US