D-0494-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- July 2, 2025
- Initiation Date
- May 28, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 87,840 bottles
Product Description
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
Distribution Pattern
US Nationwide.
Code Information
Batch TZ1236, Exp Date: 11/30/2025