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U.S. Department of Health and Human Services

Safety

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Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials -- Recall

Audience: Hospital risk managers, surgical center staff, pharmacists

[UPDATED 11/03/2009] Recall expanded to include all lots of product.

[Posted 10/21/2009] American Regent and FDA notified healthcare professionals of a voluntary recall of all lots of Ketorolac Tromethamine Injection, USP 30 mg/mL, including NDC# 0517-0801-25 [30 mg/mL 1mL Single Dose Vial] and  NDC# 0517-0902-25 [30 mg/mL 2mL Single Dose Vial (60 mg/2mL)]. There is a potential for particulate matter in conjunction with crystallization that may be present in the product, which may result in adverse events such as  obstruction of blood vessels which can induce pulmonary emboli or thrombosis, activate platelets and/or neutrophils to induce anaphylactic reactions. Other adverse effects associated with the injection of particulate matter include foreign body granulomas, and local irritation at the injection site.

This recall does not include other concentrations of American Regent Ketorolac Tromethamine Injection. The product was distributed to wholesalers and distributors nationwide. Hospitals, surgi-centers, clinics and other healthcare facilities should not use any American Regent Ketorolac Tromethamine Injection, USP Injection 30 mg/mL for patient care and should immediately quarantine any product for return. 

[10/21/2009 - Press Release - American Regent]

[11/03/2009 - Press Release - American Regent]