Drug product
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).
D-0036-2026
Product summary
- Event
- Event 97711
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0036-2026
Official wording
Reason: Presence of Particulate Matter: Particulate matter identified as glass
Code information: Lot #: AS1240347A, Exp Date 09/2026; AS1240144A, Exp Date 05/2026; AS1240145A, AS1240146A, Exp Date 06/2026; AS1250295A, Exp Date 05/2027.
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter