Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex...
FDA Recall #D-0677-2025 — Class II — September 5, 2025
Product Description
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
Recalling Firm
Apotex Corp. — Weston, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
493,468 bottles
Distribution
Nationwide in the US
Code Information
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated