Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, ...
FDA Recall #D-0457-2025 — Class II — May 28, 2025
Product Description
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 for Recall
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Recalling Firm
Apotex Corp. — Weston, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
20,648 bottles
Distribution
US Nationwide.
Code Information
Batch # TZ5589, Exp Date: 01/31/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated