Drug 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
D-0457-2025
Product summary
- Firm
- Apotex Corp.
- Event
- Event 96953
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 20,648 bottles
- Official record key
drug-enforcement:D-0457-2025
Official wording
Reason: Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Code information: Batch # TZ5589, Exp Date: 01/31/2026
Distribution pattern: US Nationwide.
Derived failure modes
-
Unknown
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.