Three lots of Bedford Laboratories’ Cytarabine, an anticancer drug, has been recalled because it may not be sterile.
A Cytarabine recall was announced by the FDA on February 23, after a post-release investigation of the manufacturing area determined that the company could not guarantee their sterility. There have been no adverse events or injuries reported in connection to the drug recall.
Cytarabine is used in combination with other anticancer drugs for the treatment of several kinds of leukemia.
The recall affects three lots of Cytarabine for injection, USP 1 gram per vial. The recalled lots include 2066986, with a March 31, 2014 expiration date; 2111675, with an April 30, 2014 expiration date; and 2131148, with a May 31, 2014 expiration date. All of the affected lots have an NDC number of 55390-133-01.
The company notified wholesalers, distributors and retailers, as well as health care facilities on February 16 and asked for the return of the affected products. The company warned that health care workers and facilities should not use the affected vials and should immediately quarantine any remaining recalled vials for return.
The recall comes less than a month after Bedford Laboratories had to recall one lot of acetylcysteine, used to treat acetaminophen overdoses, due to glass fragments found in vials. There were no injuries or adverse effects reported in association with those recalled vials.
Hospitals, clinics, doctors offices and patients with questions can call Bedford Laboratories Client Services at (800) 562-4797.
Patients or doctors should report any adverse reactions from these recalled vials to the MedWatch adverse event reporting program. Bedford Laboratories is also asking for anyone who experiences an adverse event to call (800) 521-5169.