FDAFDA · Food and drugs·Recall number D-0036-2026
Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Mfd. by: ASPIRO PHARMA LIMITED, Telangana - 502281, INDIA., U.S. Contact Number: 1-866-495-1995, NDC 31722-307-25 (Carton), 31722-307-02 (Vial label).
Published October 29, 2025 · Recall initiated: October 1, 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
Presence of Particulate Matter: Particulate matter identified as glass
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- KETOROLAC TROMETHAMINE
- Manufacturer
- Aspiro Pharma Limited
- Distributor
- Nationwide within the United States
- Lot
- Lot #: AS1240347A, Exp Date 09/2026; AS1240144A, Exp Date 05/2026; AS1240145A, AS1240146A, Exp Date 06/2026; AS1250295A, Exp Date 05/2027.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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