Class II

Drug Recall: 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

Apotex Corp. · May 28, 2025

Reason for Recall

Lack of Assurance of Sterility

Distribution

US Nationwide.

States Affected

NATIONWIDE

Quantity Affected

87,840 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0494-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.