Recalls / Class II
Class IID-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.
- Brand name
- Ketorolac Tromethamine
- Generic name
- Ketorolac Tromethamine
- Active ingredient
- Ketorolac Tromethamine
- Route
- Ophthalmic
- NDC
- 60505-1003
- FDA application
- ANDA076109
- Affected lot / code info
- 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
Why it was recalled
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Recalling firm
- Firm
- Apotex Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2400 N Commerce Pkwy Ste 400, N/A, Weston, Florida 33326-3253
Distribution
- Quantity
- 493,468 bottles
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2025-09-05
- FDA classified
- 2025-09-30
- Posted by FDA
- 2025-10-08
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0677-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.