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U.S. Department of Health and Human Services

Safety

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Methotrexate for Injection (preservative free)

Audience: Oncologists, dermatologists, rheumatologists, and other healthcare professionals

[Posted 12/13/2005] FDA and 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, because the active drug substance (“ADS”) used to manufacture Lot # 859142, contained low levels of ethylene glycol. Preservative-free methotrexate is the only formulation that is acceptable for intrathecal administration. Healthcare professionals and suppliers should not distribute these vials and should contact Bedford Laboratories for return instructions. Consumers that have received this product and have questions should contact their physicians.

[December 8, 2005 - Press Release - Bedford Laboratories]