FDA recall D-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).

Reason for recall

Presence of Particulate Matter: Particulate matter identified as glass

Distribution

Nationwide within the United States

Key facts

Status

Ongoing

Initiation date

2025-10-01

Report date

2025-10-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Siddipet (District), India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0036-2026