Cytarabine for Injection, 1 gm/vial [Bedford Labs]: Recall: Risk of Lack of Sterility

ISSUE: Bedford Laboratories announced a nationwide recall of three lots of cytarabine for injection—2066986, 2111675, and 2131148—because vials have a potential risk of a lack of sterility. The risk was determined from a post-release investigation of the manufacturing area.

BACKGROUND: Cytarabine in combination with other approved anticancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and children. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of cytarabine is indicated in the prophylaxis and treatment of meningeal leukemia

RECOMMENDATIONS: Hospitals, emergency rooms, clinics, physician offices and other healthcare facilities and providers should not use the product lots listed for patient care and should immediately quarantine any product for return. Should wholesalers/distributors/retailers still have product which is being recalled, they should stop use and contact Bedford Laboratories Client Services at 800.562.4797
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178




Recall -- Firm Press Release

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Bedford Laboratories? Issues Nationwide Voluntary Recall
of Cytarabine for Injection, USP, 1 Gram per Vial

Contact:
Consumer:
Client Services Department
800-562-4797

Media:
Jason Kurtz
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

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.

Hospitals, emergency rooms, clinics, physician offices and other health care facilities and providers, or patients with product quality compliance, medical or other questions concerning the use of the product or reasons for this recall should contact the Client Services Department at 800-562-4797 between 8am and 5pm EST Monday - Friday. Any adverse reactions experienced with any of the lots reported in this release should be also reported to 800-521-5169

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program online, or regular mail or by fax.

Online: www.fda.gov/medwatch/report.htm1 Regular Mail: Use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/medwatch/getforms.htm2 Mail to address on the pre-addressed form. Fax: 1-800-FDA-0178 ###

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