Recalls / Class II
Class IID-0494-2025
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
- Brand name
- Ketorolac Tromethamine
- Generic name
- Ketorolac Tromethamine
- Active ingredient
- Ketorolac Tromethamine
- Route
- Ophthalmic
- NDC
- 60505-1003
- FDA application
- ANDA076109
- Affected lot / code info
- Batch TZ1236, Exp Date: 11/30/2025
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Apotex Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2400 N Commerce Pkwy Ste 400, Weston, Florida 33326-3253
Distribution
- Quantity
- 87,840 bottles
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2025-05-28
- FDA classified
- 2025-06-25
- Posted by FDA
- 2025-07-02
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0494-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.