Recall: D-0494-2025

Class II - Potentially Harmful

Class IIClassification

2025-05-28Initiated

OngoingStatus

Apotex Corp.Firm

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

Lack of Assurance of Sterility

Distribution

US Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.