FDA Announces Recall of One Lot of Methotrexate
Bedford Laboratories recalls Lot #859142 because of possible ethylene glycol contaminant
WEDNESDAY, Dec. 14 (HealthDay News) -- The U.S. Food and Drug Administration announced Tuesday the recall of one lot of injectable methotrexate because the active drug substance used to make it contained small amounts of ethylene glycol. Bedford Laboratories, a division of Ben Venue Laboratories, Inc. of Bedford, Ohio, voluntarily recalled Lot #859142.
"Human use of preservative-free methotrexate formulations for intrathecal administration containing ethylene glycol is not permissible," according to a statement from the company.
The prescription product was distributed across the United States in October and November of 2005 to wholesalers and distributors who supply hospitals. No related serious adverse health effects have been reported.
Customers with any vials of this lot of injectable methotrexate should immediately stop its use and distribution and contact Bedford Laboratories at 1-800-562-4797. Consumers with questions should also call the same number from 8 a.m. to 5 p.m. (EST), according to the statement.