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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Bedford Laboratories Recalls One Lot of Famotidine Injection

Contact:
Bedford Laboratories Customer Service Department
1-800-562-4797

FOR IMMEDIATE RELEASE --Bedford, OH -- April 28, 2005 --- Bedford Laboratories, a division of Ben Venue Laboratories, Inc., Bedford, Ohio, announced that it is voluntarily recalling one lot of Famotidine Injection, 20 mg/2 mL (NDC 55390-029-10), Lot# 609336, exp. 04/06, due to a lack of sterility assurance.

This prescription product was distributed in August 2004 throughout the United States to wholesalers and distributors, who further distributed the product to hospitals. Customers that have any vials of this lot of Famotidine Injection should discontinue distribution and use of the lot immediately and contact Bedford Laboratories Customer Service Department (1-800-562-4797) for a returned goods authorization.

Bedford Laboratories is working with the USFDA on this recall. No serious health or safety reports have been received that are attributed to this situation.

Bedford Laboratories supplies the US and International markets with multisource and specialty injectable products. Headquartered in Bedford, Ohio, Bedford Laboratories is a division of Ben Venue Laboratories, Inc., a subsidiary of Boehringer Ingelheim Corporation based in Ridgefield, CT, and a member of the Boehringer Ingelheim group of companies.

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