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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 Labs Initiates Nationwide Recall of Injectable Methotrexate

Contact:
Marybeth C. McGuire
(203) 798 - 4801

FOR IMMEDIATE RELEASE -- Ridgefield, CT - December 8, 2005 -- Bedford Laboratories, a division of Ben Venue Laboratories, Inc., Bedford, Ohio, announced that it is voluntarily recalling one lot of Methotrexate for Injection (preservative free), USP 1 gram per vial (NDC 55390-143-01), Lot# 859142, exp 09/07. Bedford Laboratories was informed by the manufacturer of the Methotrexate USP active drug substance (“ADS”) that the ADS used to manufacture Lot # 859142, contained low levels of ethylene glycol. Human use of preservative free Methotrexate formulations for intrathecal administration containing ethylene glycol is not permissible. Consumers that have received this product and have questions should contact their physicians.

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

The prescription product was distributed throughout the United States in October and November 2005 to wholesalers and distributors, who further distribute the product to hospitals. Customers that have any vials of this one lot of Methotrexate for Injection have been instructed to discontinue distribution and use of this lot immediately and contact Bedford Laboratories Customer Service Department (1-800-562-4797) for a returned goods authorization. Consumers that have questions regarding this recall should also contact the Bedford Customer Service Department at 1-800-562-4797, between the hours of 8 a.m - 5 p.m (EST).

Bedford Laboratories supplies the US and International markets with multisource and specialty injectable products. Headquartered in Bedford, OH, 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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