Drug 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
D-0494-2025
Product summary
- Firm
- Apotex Corp.
- Event
- Event 96954
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 87,840 bottles
- Official record key
drug-enforcement:D-0494-2025
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch TZ1236, Exp Date: 11/30/2025
Distribution pattern: US Nationwide.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility