FDA-Drug2025-06-11Class II

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

Apotex Corp.
Hazard

Defective Container: This recall is being initiated due to a leaking unit stored horizontally.

Sold states
US Nationwide.
Affected count
20,648 bottles
Manufactured in
2400 N Commerce Pkwy Ste 400, N/A, Weston, FL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0457-2025

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