Recalls / Class II
Class IID-0036-2026
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).
- Brand name
- Ketorolac Tromethamine
- Generic name
- Ketorolac Tromethamine
- Active ingredient
- Ketorolac Tromethamine
- Route
- Intramuscular, Intravenous
- NDCs
- 31722-305, 31722-306, 31722-307
- FDA application
- ANDA217166
- Affected 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.
Why it was recalled
Presence of Particulate Matter: Particulate matter identified as glass
Recalling firm
- Firm
- Aspiro Pharma Limited
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Survey No. 321, Biotech Park, Phase Iii, Karkapatla Village, Markook (Mandal), Siddipet (District), N/A, India
Distribution
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2025-10-01
- FDA classified
- 2025-10-21
- Posted by FDA
- 2025-10-29
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0036-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.