FDARecalled Oct 8, 2025 · #D-0677-2025
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, ND...
Hazard
Class II — temporary health risk
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Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns Classification: Class II Distribution: Nationwide in the US
Product details
- 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.
- Type
- Drugs
- Manufacturer
- Apotex Corp.
- Model numbers
- —
- UPCs
- 360505100316