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Recall Of Vecuronium Bromide For Injection

Vecuronium Bromide is used as an adjunct to general anesthesia, which facilitates endotracheal intubation and provides skeletal muscle relaxation during surgery or mechanical ventilation. Bedford Laboratories announced on June 28, 2012 a nationwide voluntary hospital/user-level recall for the drug Vecuronium Bromide for injection. The voluntary recall is being conducted because of the discovery of particulate matter in a small number of vials within the list below. The discovery of the particulate matter was made post-release inspection and there haven’t been any reports of any adverse events to date for the lot being recalled.

The particulate matter has been recognized as a potential health hazard and adverse reactions such as:

  • Vein irritation
  • Phlebitis
  • Clinically occult pulmonary granulomas detected at routine autopsy examination
  • Local tissue infarction
  • Severe pulmonary dysfunction
  • Occlusion of capillaries and arteries
  • Anaphylactic shock
  • Death

The recalled products were distributed as:

  • 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

Notification of the Vecuronium Bromide for injection lot that are listed above are being sent to customers who have received this product. Health practitioners who have received this lot of the product are instructed to halt all use of the product and immediately quarantine it for return. If you have any questions you may contact Bedford Laboratories Client Services directly at 800-562-4797 between 8 a.m. and 5 p.m. Eastern time, Monday through Friday. If any adverse reactions are expericened with the lot reported in the FDA release should be reported to Bedford Laboratories at 800-521-5169 and the FDA’s MedWatch Adverse Event Reporting program in any of the following ways:

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

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