Bedford Laboratories (Bedford, OH, www.bedfordlabs.com), a division of Ben Venue Laboratories, Inc., (Bedford, OH, www.benvenue.com) voluntarily recalled one lot of famotidine injection, 20 mg/2-mL (NDC 55390-029-10), lot no. 609336, with an expiration date of April 2006, because of a lack of sterility assurance.

The prescription product was distributed in August 2004 throughout the United States to wholesalers and distributors, who further distributed the product to hospitals. According to an FDA posting, customers that have any vials of this lot of famotidine injection should discontinue distribution and use of the drug immediately and contact Bedford Laboratories' customer service department (tel. 800.562.4797) for a returned goods authorization.

Bedford Laboratories is working with FDA on this recall, and to date no serious health or safety reports have been attributed to the defective lot.