RECALL CONDUCTED DUE TO A POST-RELEASE MANUFACTURING INVESTIGATION
Bedford Laboratories, a division of Boehringer-Ingelheim announced on February 12, 2012 a recall for three lots of Cytarabine for Injection, USP.
This “voluntary” market recall, announced with the knowledge of the FDA 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 three lots.
What is particularly of interest within this “Recall Notice” is the recall following a “post-release investigation”. Has anyone ever encountered this type of recall notice? Please note that Bedford Laboratories is the generic operation within Ben Venue Laboratories and a wholly owned subsidiary of Boehringer-Ingelheim which has had a recent history of Form FDA 483s from the FDA and the cessation of the manufacture of many parenteral drugs.
Recall — Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Bedford Laboratories™ Issues Nationwide Voluntary Recall
of Cytarabine for Injection, USP, 1 Gram per Vial
Contact:
Consumer:
Client Services Department
800-562-4797 800-562-4797
Media:
Jason Kurtz
440-201-3668 440-201-3668
jason.kurtz@boehringer-ingelheim.com
FOR IMMEDIATE RELEASE – February 16, 2012 – Bedford Lboratories™ announces a nationwide voluntary recall for the following three lots of Cytarabine for Injection, USP:
Cytarabine for injection, USP 1 gram per viral – NDC #55390-133-01
- Lot 2066986 – Exp. Date March 31, 2014
- Lot 2111675 – Exp. Date April, 30, 2014
- Lot 2131148 – Exp. 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.
Cytarabine in combination with other approved anticancer drugs is indicated for remission induction in acute non-lymphocytic luekemia of adults and children. it has also been found useful in the treatment acute lymphocytic luekemia and the blast phase of chronic myelocytic luekemia. Intrathecal administration of cytarabine is indicated in the prophylaxis and treatment of meningeal luekemia.
Initial recall notification of the Cytarabine for Injection lots listed above were sent to impacted wholesalers and distributors by overnight courier and arranged for return of all recalled product. hospitals, emergency rooms, clinics, physician offices and other healthcare facilities and providers should not use the product lots listed above for patient care and should immediately quarantine any product for return. Should wholesalers/distributors/retailers still have the product which is being recalled, they should stop use and contact Bedford Laboratories Client Services at 800-562-4797 800-562-4797
Bedford Laboratories has informed the U.S. Food and Drug Administration (FDA) of its actions and is maintaining ongoing discussion with the agency. This voluntary recall is being conducted with the knowledge of the FDA.
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