D-0457-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- June 11, 2025
- Initiation Date
- May 28, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20,648 bottles
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.
Distribution Pattern
US Nationwide.
Code Information
Batch # TZ5589, Exp Date: 01/31/2026