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vecuronium FDA Alerts

The FDA Alert(s) below may be specifically about vecuronium or relate to a group or class of drugs which include vecuronium.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for vecuronium

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Jan 8, 2019

Audience: Health Professional, Pharmacy

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder) to the hospital level. The Vecuronium Bromide for Injection has been found to contain particulate matter identified as glass.

The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening. To date, SPII has not received any reports of adverse events related to this recall.

Vecuronium Bromide for Injection is used as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation and is packaged in a glass vial; ten vials per carton. Vecuronium Bromide for Injection should be administered by or under the supervision of experienced clinicians and must be reconstituted prior to use. The affected Vecuronium Bromide for Injection, include the following:

Product NameLot NumberNDC NumberExpiration DateNumber of Units
Vecuronium Bromide for Injection, 20 mgJKS0400A47335-932-44 [carton]
47335-932-40 [vial]
03/20191384 cartons
Vecuronium Bromide for Injection, 10 mgJKS0443A47335-931-44 [carton]
47335-931-40 [vial]
03/20194404 cartons
Vecuronium Bromide for Injection, 10 mgJKS0444A47335-931-44 [carton]
47335-931-40 [vial]
03/20193744 cartons
Vecuronium Bromide for Injection, 10 mgJKS0477A47335-931-44 [carton]
47335-931-40 [vial]
03/20194386 cartons

The product can be identified by vial or carton labeled as Vecuronium Bromide for Injection containing the specific Lot Number and Expiration Dates mentioned above.

This product was distributed nationwide to wholesale customers and medical facilities.

On January 3, 2019, SPII notified its distributors and customers through its 3rd party, Recall Coordinator (Inmar Inc.), via FedEx standard overnight shipping and has arranged for return via prepaid FedEx Ground shipping of all recalled products.
Distributors and medical facilities that have Vecuronium Bromide for Injection, which is being recalled, should stop using and return it to place of purchase or as directed in the recall notification.

Consumers with questions regarding this recall can contact SPII by calling 1-800-406-7984 Monday through Friday between 8:00 am to 5:00 pm EST or e-mailing drug.safetyUSA@sunpharma.comConsumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Vecuronium Bromide For Injection by Sagent Pharmaceuticals, Inc.: Recall - Elevated Impurity Result Detected

Jun 10, 2013

Audience: Pharmacy, Patient, Health Professional

ISSUE: Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of three lots of Vecuronium Bromide for Injection 10mg (NDC number 25021-657-10) manufactured by Mustafa Nevzat Ilac Sanayii A.S. (MN Pharmaceuticals) and distributed by Sagent.  Sagent has initiated this voluntary recall of Vecuronium Bromide for Injection to the user level due to the  discovery of an elevated impurity result detected during routine quality testing of stability samples at the 18-month interval. The elevated impurity result has the potential to result in prolonged neuromuscular blockade for critically ill patients with renal failure. 

BACKGROUND: Vecuronium Bromide for Injection is a neuromuscular blocking agent indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation and is supplied in a glass vial. The lot numbers being recalled are: 11I30481A, 11I30721A and 11I32581A, which were distributed to hospitals, wholesalers and distributors nationwide from January 2012 through May 2012. Sagent is not aware of any adverse patient events resulting from the use of this product and is continuing its diligent investigation of the situation.

RECOMMENDATION: Sagent’s Distributor, DDN, is notifying Sagent’s  distributors and customers by fax, email and certified mail and is arranging for return of all recalled product. Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return all recalled lots of the product. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product. Any questions about returning unused product should be directed to the customer call center at (866) 625-1618 M-F 8am-7pm CST.   

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products 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

[06/07/2013 - Firm Press Release]

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

Jun 29, 2012

Audience: Risk Manager, Pharmacy, Surgery, Anesthesia

 

[Posted 06/29/2012]

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] 

Bedford Laboratories Polymyxin B For Injection USP And Vecuronium Bromide For Injection: Recall - Glass Particles

Jan 12, 2012

Audience: Pharmacy, Risk Manager

ISSUE: Bedford Laboratories issued guidance on the nationwide voluntary product recalls originally issued on August 2, 2011. The recalls were initiated after the discovery of a visible glass particle in a limited number of vials within the lots listed below to the user level.

  • Polymyxin B for Injection USP, 500,000 Units per vial – NDC #55390-139-10
    Lot 1942980 – Exp. Date August 2013 and Lot 1895027 – Exp. Date June 2013
  • Vecuronium Bromide for Injection, 10 mg per vial – NDC #55390-037-10
    Lot 1865067 – Exp. Date May 2012
  • Vecuronium Bromide for Injection, 20 mg per vial – NDC #55390-039-10
    Lot 1865069 – Exp. Date February 2012

Particulate matter in injections can be harmful when introduced into the bloodstream. Potential adverse events after intravenous administration may include vein irritation and phlebitis, pulmonary dysfunction and granulomas, local tissue infarction, occlusion of capillaries and arteries, anaphylactic shock, and death. The introduction of particulate matter via the intrathecal route into the cerebrospinal fluid may serve as a nidus for the development of chemical meningitis. Introduction of a foreign body to the eye via topical or subconjuntive routes can cause corneal abrasion/laceration, lacrimal tear and general irritation. To date, there have been no reports of adverse events for the lots being recalled.

BACKGROUND: Polymyxin B is indicated in the treatment of acute infections caused by susceptible strains of Pseudomonas aeruginosa. 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: Hospitals, emergency rooms, clinics, physician offices and other healthcare facilities and providers should not use the product lots listed above for patient care and should immediately quarantine any product for return.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products 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


[01/10/2012 - Press Release - Bedford Laboratories]
[01/11/2012 - Product Photos - FDA]

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