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Bedford Laboratories Broadens Voluntary Recall of Leucovorin Calcium Injection USP


9/18/2012 11:08:44 AM

BEDFORD, Ohio, Sept. 18, 2012 /PRNewswire/ -- Bedford Laboratories today announced the expansion of its previous nationwide voluntary recall for Leucovorin Calcium Liquid Injection:

Product Description

NDC

Package Size

Lot#/Expiration Date

First Ship Date

Last Ship

Date

Leucovorin Calcium Injection,
500mg SDV Bedford Label

55390-009-01

1 pack

2017619 11/30/2012

2017621 01/31/2013

2038375 03/31/2013

2065418 06/30/2013

2067176 06/30/2013

2067177 06/30/2013

12/13/2010

02/23/2011

06/13/2011

08/02/2011

09/02/2011

12/19/2011

02/14/2011

05/26/2011

08/17/2011

09/06/2011

12/19/2011

12/28/2011

Leucovorin Calcium Injection, 500mg SDV NOVA PLUS® Label

55390-826-01

1 pack

2067178A 06/30/2013

08/29/2011

11/07/2011

(Logo: http://photos.prnewswire.com/prnh/20070809/CLTH157LOGO )

On July 3, 2012, Bedford Laboratories announced the nationwide voluntary recall of two lots of Leucovorin Calcium Injection USP to the Hospital/User level. This decision was made due to a field product complaint in which Bedford Laboratories found visible crystalline particulate matter in a small number of vials within the identified lots. On September 14, 2012, the recall was broadened to include all lots of Leucovorin Calcium Injection USP within expiry that have been distributed due to the potential for crystalline particulate matter in these lots. To date, there have been no reports of any adverse events for the lots being recalled.

The particulate matter has been identified as active drug substance and not foreign material or contamination. Particulate matter has been recognized as a potential health hazard. Adverse reactions may include vein irritation and phlebitis, clinically occult pulmonary granulomas detected at routine autopsy examination, local tissue infarction, severe pulmonary dysfunction, occlusion of capillaries and arteries, anaphylactic shock and death.

Leucovorin Calcium rescue is indicated after high-dose methotrexate therapy in osteosarcoma. Leucovorin Calcium is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists; the treatment of megaloblastic anemias due to folic acid deficiency when oral therapy is not feasible; and for use in combination with 5-fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer.

Please note: This recall is for lots of the liquid form of the injection. This does not affect the lyophilized powder (freeze dried) form of Leucovorin Calcium or any other products manufactured by Ben Venue Laboratories, Inc. or distributed by Bedford Laboratories.

Product was distributed nationwide to wholesalers, hospitals, clinics and retail outlets. As is standard practice, and as stated in the Product Package Insert, "Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit."

Notification of the Leucovorin Calcium Injection USP lots listed above is being sent by certified mail to customers who have received product from the identified lots, and Bedford Laboratories is arranging for return of all recalled products. Healthcare practitioners who had received the affected lots were instructed not to use the product and immediately quarantine it for return. Anyone with questions can contact Bedford Laboratories Client Services at 800-562-4797 between 8 a.m. and 5 p.m. Eastern time, Monday through Friday, except holidays.

Our highest priority is the delivery of safe and effective medicines for the patients who need them. Any adverse reactions experienced with the lots reported in this release should be reported to Bedford Laboratories at 800-521-5169. Adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program:

This voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About Bedford Laboratories
Bedford Laboratories, located in Bedford, Ohio, is a division of Ben Venue Laboratories. Bedford Laboratories supplies a selection of critical-care and medically necessary multisource and specialty injectable products to the healthcare marketplace. For more information, please visit http://www.BedfordLabs.com.

About Ben Venue Laboratories, Inc.
Ben Venue Laboratories, Inc. was founded in 1938 and is a leading manufacturer of highly complex, sterile injectable drug products for the global pharmaceutical industry. Ben Venue is located in Bedford, Ohio, where the company employs more than 1,300 people. For more information, visit www.benvenue.com.

SOURCE Bedford Laboratories



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