Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., T...
FDA Recall #D-0494-2025 — Class II — May 28, 2025
Product Description
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-2
Reason for Recall
Lack of Assurance of Sterility
Recalling Firm
Apotex Corp. — Weston, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
87,840 bottles
Distribution
US Nationwide.
Code Information
Batch TZ1236, Exp Date: 11/30/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated