Bedford Labs Recalls One Lot of Vecuronium Bromide for Injection, 20 mg
This recall is being posted as some veterinary clinics may use this medication in treating their patients.
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