Bedford Laboratories Issues Voluntary Hospital/User-Level Recall Of Vecuronium Bromide For Injection Preservative Free, Lot 2067134, Because Of Health Risk

Date of Recall

2012-06-29

Recall Details

- June 28, 2012 - Bedford Laboratories today announced a nationwide voluntary hospital/user‐level recall for:

Vecuronium Bromide for Injection, 20 mg vial - NDC #55390‐039‐10
Lot 2067134 - Exp. Date 5/31/2013
First Shipment - 8/8/2011
Last Shipment - 11/9/2011

Please note: This recall is for lot 2067134 only. No other lots of Vecuronium Bromide for injection Preservative Free are subject to this voluntary recall.

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

Vecuronium Bromide is indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

Notification of the Vecuronium Bromide for injection lot listed above is being sent to customers who have received product from the identified lot. 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.

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 FDA.

The discovery was made during a post‐release inspection. To date, there have been no reports of any adverse events for the lot being recalled. Our highest priority is the delivery of safe and effective medicines for the patients who need them. 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.
• Fax: 1‐800‐FDA‐0178

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.

No comments have been posted.
Be the first to add a comment!