Ketorolac Tromethamine Ophthalmic Solution recall: Sterility Concern
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for…
Why was Ketorolac Tromethamine Ophthalmic Solution recalled?
Lack of Assurance of Sterility
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch TZ1236, Exp Date: 11/30/2025
- Product
- Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for…
- Recalling firm
- Apotex Corp.
- Quantity
- 87,840 bottles
- Distribution
- US Nationwide.
- Recall date
- July 2, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)