Alerts
Ketorolac Tromethamine Injection - Voluntary Recall
October 22, 2009
American Regent is conducting a voluntary recall of all lots of ketorolac tromethamine injection 30 mg/mL. Other concentrations of ketorolac tromethamine injection are not affected by this recall. Affected lots include 30 mg/mL, 1 mL single-dose vials (NDC 0517-0801-25) and 30 mg/mL, 2 mL single-dose vials (NDC 0517-0902-25). The recalled product may contain crystals or particulate matter. Use of such product may result in adverse events related to obstruction of blood vessels (eg, pulmonary emboli and pulmonary thrombosis), anaphylactic reactions, foreign body granulomas, or local injection-site irritation.
Immediately discontinue use of any recalled product. Contact American Regent Customer Service at 1-800-645-1706 for information on returning affected lots for credit. For general questions, healthcare providers and patients may call the Professional Services Department at 1-631-924-4000.
Additional details are available at the following links:
- MedWatch Alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm187481.htm - Press Release:
http://www.fda.gov/Safety/Recalls/ucm187434.htm
Updated
October 22, 2009; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
