Vecuronium Bromide For Injection Preservative Free (Bedford Laboratories): Recall - Particulate Matter

[Posted 06/29/2012]

AUDIENCE: Risk Manager, Pharmacy, Surgery, Anesthesia

ISSUE: Bedford Laboratories issued recall of Vecuronium Bromide For Injection, 20 mg vial – NDC #55390-039-10, Lot 2067134, Exp. Date 5/31/2013 - due to the discovery of particulate matter in a small number of vials. This recall is for lot 2067134 only. 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.

To date, there have been no reports of any adverse events for the lot being recalled.

BACKGROUND: 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.

RECOMMENDATION:  Healthcare practitioners who had received the lot are instructed not to use the product and immediately quarantine it for return. Read the Firm Press Release for additional information.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• 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

[06/29/2012 - Press Release - Bedford]
[06/29/2012 - Product Photo - FDA]