FDAHealthMay 28, 2025
Apotex Corp. — 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
⚠️ Lack of Assurance of Sterility
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 28, 2025
US Nationwide.
What's affected?
- 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
- Lot code
- Batch TZ1236, Exp Date: 11/30/2025
Additional details
Batch TZ1236, Exp Date: 11/30/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 87,840 bottles.
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