FDAHealthMay 28, 2025
Apotex Corp. — 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
⚠️ Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 28, 2025
US Nationwide.
What's affected?
- 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
- Brand
- Apotex Corp.
- Lot code
- Batch # TZ5589, Exp Date: 01/31/2026
Additional details
Batch # TZ5589, Exp Date: 01/31/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 20,648 bottles.
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