Class IIReported 2025-07-02

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

Recall Number

D-0494-2025

Classification

Class II

Status

Ongoing