Class II Recall

Apotex Corp.

Product
Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston FL 33326, NDC 60505-0405-4
Reason
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Classification
Class II
Status
Ongoing
Lot
Batch # TZ5589, Exp Date: 01/31/2026
Date
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.