Vecuronium FDA Alerts

CDER Alert: Two Neuromuscular Blocking Agents - FDA Alerts Health Care Professionals to the Temporary Absence of Warning Statement on the Vial Caps

ISSUE: FDA is notifying health care professionals about the temporary absence of the “paralyzing agent” warning statement embossed on the vial caps of two neuromuscular blocking agents, vecuronium bromide for injection, 10 mg and 20 mg per vial and rocuronium bromide injection 50 mg/5 mL and 100 mg/10 mL vials.

As a temporary measure, to increase supply of these drugs, FDA is not objecting to the distribution of vecuronium bromide for injection and rocuronium bromide injection, starting June through September 2020 and June through July 2020, respectively, without the embossed “paralyzing agent” warning statement on the vial cap.

The following products are affected:
Rocuronium bromide injection by Gland Pharma and Mylan Institutional:

• NDC 68083-364-01 (Gland)
• NDC 68083-365-01 (Gland)
• NDC 67457-228-05 (Mylan)
• NDC 67457-228-10 (Mylan)

Vecuronium bromide injection manufactured by Gland Pharma and distributed by Fresenius Kabi:

• NDC 63323-781-21
• NDC 63323-782-23

BACKGROUND: Vecuronium bromide for injection and rocuronium bromide injection are commonly used to provide muscle relaxation during surgery or mechanical ventilation.

During the COVID- 19 pandemic, there has been an increased use of vecuronium bromide for injection and rocuronium bromide injection in intensive care unit (ICU) patients requiring mechanical ventilation. The COVID-19 pandemic has also caused supply chain disruptions contributing to a shortage of product components, such as embossed vial caps, used in manufacturing the container closure for these products.

Currently vecuronium bromide for injection and rocuronium bromide injection include a prominent “Paralyzing Agent” warning statement (in red bold font) on the container labeling which will remain on the vials.

RECOMMENDATION:

The FDA recommends careful handling of these neuromuscular blocking agents as it is vital to prevent medication errors that could result in serious harm or death.

Health care providers should consider the following steps:

• Add an auxiliary warning label on the vial caps to help alert health care providers that the product is a neuromuscular blocking agent.
• Avoid storing the product so that only the cap is visible.
• Utilize barcode scanning when stocking medication cabinets and preparing or administering the product.
• Check the container label to ensure the correct product is being administered.
• If these products are stored in automated dispensing cabinets, consider hospital protocols to limit access and manage override removals.

Health professionals and patients are encouraged to report adverse events and medication errors 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.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

[06/03/2020 - CDER Alert - FDA]

Source: FDA

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

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:

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.com.  Consumers 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.

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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.

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

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.accessdata.fda.gov/scripts/medwatch/index.cfm
• 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

[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.accessdata.fda.gov/scripts/medwatch/index.cfm
• 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

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.accessdata.fda.gov/scripts/medwatch/index.cfm
• 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]