FDA MedWatch – Indomethacin for Injection: Recall

ISSUE: Bedford Laboratories, a division of Ben Venue Laboratories, Inc., initiated a nationwide voluntary recall of Indomethacin for Injection, USP, 1mg Single Dose Vial (NDC #55390-299-01, Lot 1948138, Exp. Date September 2011) as it may contain particulate matter. The particulate matter has been identified as active drug substance and not foreign material or contamination. FDA states that particulate matter may provoke an immune reaction and/or lead to microinfarcts which could be serious and life threatening.

BACKGROUND: Indomethacin for injection is indicated to close a hemodynamically significant patent ductus arteriosus in premature infants, who typically have small blood vessels.

RECOMMENDATION: Hospitals, emergency rooms, clinics, physician offices and other healthcare facilities and providers should not use Bedford Laboratories’ Indomethacin Injection, USP 1mg Vials, with Lot 1948138, for patient care and should immediately quarantine any product for return.

Those with questions about the return or recall process, please call the Bedford Customer Service Department at 1.800.562.4797.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

CLICK HERE ror more information.