D-0494-2025 Class II Ongoing
FDA drug recall D-0494-2025 was initiated by Apotex Corp. on May 28, 2025 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: 87,840 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Jul 2, 2025
- Initiation Date
- May 28, 2025
- 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0494-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026