FDAFDA · Food and drugs·Recall number D-0457-2025
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
Published June 11, 2025 · Recall initiated: May 28, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Apotex Corp.
- Distributor
- US Nationwide.
- Lot
- Batch # TZ5589, Exp Date: 01/31/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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