FDA recall D-0457-2025

Apotex Corp. · Class II · drug

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

Reason for recall

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

Distribution

US Nationwide.

Key facts

Status: Ongoing
Initiation date: 2025-05-28
Report date: 2025-06-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Weston, FL, United States

Primary source

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