(ChemotherapyAdvisor) – Bedford Laboratories announced a nationwide voluntary recall February 16 for three lots of cytarabine for injection, USP 1g per vial (NDC #55390-133-01):
• Lot 2066986 – Expiration date March 31, 2014
• Lot 2111675 – Expiration date April 30, 2014
• Lot 2131148 – Expiration date May 31, 2014
“This voluntary market recall is being conducted due to a post-release investigation of the manufacturing area which determined a potential elevated risk of a lack of sterility assurance for these specific lots. To date, there have been no reports of any adverse events for the lots being recalled,” the manufacturer noted.
These product lot numbers listed should not be used for patient care and should be quarantined immediately for return. Contact Bedford Laboratories Client Services Department at 800.562.4797 between 8 a.m. and 5 p.m., EST, Monday through Friday. Any adverse reactions experienced with any of the lots should be reported to 800.521.5169.
Adverse reactions or quality problems experienced with use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program: www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.