Aspiro Pharma Limited: 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 P
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Aspiro Pharma Limited
- 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).
- Reason / hazard
- Presence of Particulate Matter: Particulate matter identified as glass
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Nationwide within the United States
- Recall initiated
- 2025-10-01
- Code info
- Lot #: AS1240347A, Exp Date 09/2026; AS1240144A, Exp Date 05/2026; AS1240145A, AS1240146A, Exp Date 06/2026; AS1250295A, Exp Date 05/2027.
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Siddipet (District)
- Country
- India
- Event id
- 97711
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