Apotex Corp. recalls Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada
Recalled July 2, 2025 · FDA recall D-0494-2025 · Apotex
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
87,840 bottles
Sold at
US Nationwide.
Description
Lack of Assurance of Sterility
Product
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
Manufacturer(s)
Apotex Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →