The Food and Drug Administration's MedWatch program has announced a voluntary recall of one lot of Methotrexate for Injection (preservative free) due to the presence of low levels of ethylene glycol.
Bedford Laboratories, a division of Ben Venue Laboratories Inc., last month announced a recall of Methotrexate for Injection (preservative free), USP 1 gram per vial (NDC 55390–143–01), Lot #859142, exp. 09/07. The company was informed by the manufacturer that the active drug substance used to create this lot contained low levels of ethylene glycol, a solvent used in antifreeze among other products.<[par]>
Methotrexate is an antimetabolite used in the treatment of adult rheumatoid arthritis, severe psoriasis, and certain neoplastic diseases.
Methotrexate for Injection was distributed to wholesalers and hospitals throughout the United States in October and November 2005.
Bedford Laboratories instructed customers to discontinue distribution and use of this lot, and to call the company at 800-562-4797 with any questions.