FDAFDA · Food and drugs·Recall number D-0494-2025
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
Published July 2, 2025 · Recall initiated: May 28, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- KETOROLAC TROMETHAMINE
- Manufacturer
- Apotex Corp.
- Distributor
- US Nationwide.
- Lot
- Batch TZ1236, Exp Date: 11/30/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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