Recall D-0494-2025

US Class II Ongoing · initiated 2025-05-28

Recalling firm

Apotex Corp., FL

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

Reason for recall

Lack of Assurance of Sterility

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