The FDA and American Regent have notified healthcare professionals of a voluntary nationwide recall of all lots of its ketorolac tromethamine injection 30mg/mL. This recall is due to the potential that particulate matter in conjunction with crystallization 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 include foreign body granulomas and local irritation at the injection site. Healthcare facilities should immediately quarantine any of the recalled ketorolac tromethamine injection products for return.
This recall does not affect ketorolac tromethamine injection 15mg/mL, 1mL single-dose vial; NDC# 0517-0601-25. The products being recalled include:
- Ketorolac tromethamine injection 30mg/mL, 1mL single-dose vial; NDC# 0517-0801-25
- Ketorolac tromethamine injection 30mg/mL, 2mL single-dose vial; NDC# 0517-0902-25
Ketorolac tromethamine for IV or IM injection is a nonsteroidal antiinflammatory drug (NSAID) indicated for the management of moderately severe, acute pain requiring opioid-level analgesia.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm187481.htm.