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Bedford Labs initiates voluntary recall of Indomethacin for Injection

Bedford Laboratories, a division of Ben Venue Laboratories, has initiated a voluntary recall of the Indomethacin for Injection, USP, 1mg Single Dose Vial of Lot 1948138.

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

The voluntary recall was initiated because some of the vials of lot number 1948138 may contain particulate matter.

The US Food and Drug Administration (FDA) has stated that particulate matter may provoke an immune reaction and/or lead to microinfarcts which could be serious and life threatening.

The FDA concluded that 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.

Bedford Laboratories said it will credit accounts for all returned product with lot 1948138.