Class IIReported 2025-06-11

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.

Recall Number

D-0457-2025

Classification

Class II

Status

Ongoing