Status
Ongoing
Drug Enforcement D-0457-2025
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Classification
Class II
Report Date
June 11, 2025
Termination Date
—
Product Information
- 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
- Product quantity
- 20,648 bottles
- Reason for recall
- Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- US Nationwide.
Location & Firm
- Recalling firm
- Apotex Corp.
- Address
-
2400 N Commerce Pkwy Ste 400, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0457-2025
- Event ID
- 96953
- Recall initiation date
- May 28, 2025
- Center classification date
- June 3, 2025
- Code info
- Batch # TZ5589, Exp Date: 01/31/2026
- More code info
- —