Bedford Laboratories has recalled one lot of preservative-free Methotrexate for Injection because the active ingredient was contaminated with low levels of the preservative ethylene glycol. The affected lot is #859142, with a September 2007 expiry. Health professionals should not distribute the 1-gm vials (NDC 55390-143-01) and should contact Bedford Labs for return instructions. The complete FDA MedWatch safety summary is at http://www.fda.gov/medwatch/safety/2005/safety05.htm#Methotrexate.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.