Indomethacin for Injection by Bedford
June 16, 2011
Bedford Laboratories is recalling one lot of indomethacin 1 mg single dose vials for injection (NDC 55390-0299-01). Some vials contain active drug particulate matter. The specific lot number being recalled is 1948138 (expiration date 9/2011). No other lot numbers of indomethacin are affected by this recall.
Indomethacin is labeled for use in premature infants to close a hemodynamically significant patent ductus arteriosus. FDA states that particulate matter may lead to an immunological response or microinfarct, which could be serious and even life threatening.
Do not use indomethacin injection manufactured by Bedford Laboratories with this lot number. Quarantine any affected product and return to Bedford Laboratories for an account credit. Healthcare providers with questions may contact Bedford Laboratories at 1-800-562-4797, weekdays from 8:00 AM to 5:30 PM EST.
Additional information is available at the following links:
- MedWatch alert (June 15, 2011):
- Bedford Press Release (June 13, 2011):
June 16, 2011; University of Utah, Drug Information Service. Copyright 2011, Drug Information Service, University of Utah, Salt Lake City, UT.