Class II
Ongoing
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).
This recall is currently active, issued October 29, 2025. It was issued by Aspiro Pharma Limited.
- Company
- Aspiro Pharma Limited
- Recall Initiated
- October 1, 2025
- Posted
- October 29, 2025
- Recall Number
- D-0036-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Siddipet (District), India
- Official Source
- View on FDA website ↗
Reason for Recall
Presence of Particulate Matter: Particulate matter identified as glass
Distribution
Nationwide within the United States
Lot / Code Info
Lot #: AS1240347A, Exp Date 09/2026; AS1240144A, Exp Date 05/2026; AS1240145A, AS1240146A, Exp Date 06/2026; AS1250295A, Exp Date 05/2027.
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