Drug recall D-0677-2025
Product
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-1.
Reason for recall
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Lots and codes
Batch # VA0444, exp. date 01/2026 Batch # VA4608, exp. date 01/2026 Batch # TZ7016, exp. date 12/2025 UPC on Bottles: (01)0(03)60505100316 UPC on Cartons: 360505100316
Recall details
- Recalling firm
- Apotex Corp., Weston, FL
- Quantity
- 493,468 bottles
- Distribution
- Nationwide in the US
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 5, 2025
Related products
- Ketorolac Tromethamine – drug information
- NDC 60505-1003 Ketorolac Tromethamine · Ketorolac Tromethamine 5 mg/mL · Apotex Corp.