Recalling firm
Apotex Corp.
Product type
Drug
Status
Ongoing
Report date
2025-06-11
Distribution
US Nationwide.
Firm state
FL
Product quantity
20,648 bottles
Initiated by
Voluntary: Firm initiated
Reason for recall
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Product description
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
Code / lot info
Batch # TZ5589, Exp Date: 01/31/2026
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.