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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 Hospital/User‐Level Recall Of Leucovorin Calcium Injection

 

Contact:
Consumer:
For Information: 1-800-562-4797
Adverse Reactions: 1-800‐521‐5169

Media:
Marjorie Moeling, 440-703-7525
marjorie.moeling@boehringer‐ingelheim.com
 

FOR IMMEDIATE RELEASE - July 3, 2012 -Bedford Laboratories™ today announced a nationwide voluntary hospital/user‐level recall for:

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

2017620‐1/31/2013
2038374‐2/28/2013

1/31/2011
5/17/2011

2/24/2011
6/15/2011

Leucovorin Calcium Injection,
500mg SDV NOVA PLUS®
Label

55390‐826‐01

1 pack

2038374A – 2/28/2013

5/16/2011

6/29/2011

 Please note: This recall is for lots listed in the above table only. No other lots of Leucovorin Calcium Injection are subject to
this voluntary recall.

This voluntary recall is being conducted due to the discovery of visible crystalline particulate matter in a small number of vials
within the lots listed above. 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.

Notification of the Leucovorin Calcium lots listed above is being sent to customers who have received product from the
identified lots. Healthcare practitioners who had received the lot 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.

Any adverse reactions experienced with the lot 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:

􀂃 Online: www.fda.gov/medwatch/report.htm

􀂃 Regular mail: Use postage‐paid, pre‐addressed Form FDA 3500 available at: www.fda.gov/medwatch/getforms.htm. Mail to address on the pre‐addressed form.
Bedford Laboratories, a division of Ben Venue Laboratories, Inc. 300 Northfield Road, Bedford, OH 44146 • U.S.A. •Phone: 440.232.3320 • Fax: 440.232.6264 www.bedfordlabs.com

􀂃 Fax: 1‐800‐FDA‐0178

Bedford Laboratories has informed the U.S. Food and Drug Administration (FDA) of its actions and is maintaining ongoing
discussions with the agency. This voluntary recall is being conducted with the knowledge of the U.S. FDA.

The discovery was made due to a field product complaint for visible crystalline particulate and discovery of crystalline
particulate in a retained sample. To date, there have been no reports of any adverse events for the lots being recalled. Our
highest priority is the delivery of safe and effective medicines for the patients who need them.

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.”

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.

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