Rocuronium FDA Alerts
The FDA Alerts below may be specifically about rocuronium or relate to a group or class of drugs which include rocuronium.
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.
Recent FDA Alerts for rocuronium
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.
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]
Injectable Products by SCA Pharmaceuticals: Recall - Potential Contamination
ISSUE: SCA Pharmaceuticals LLC (“SCA Pharmaceuticals”) is voluntarily recalling various lots of injectable products to the hospital level. There is a potential for the products to contain microbial contamination. See the recall notice for a full list of products.
BACKGROUND: Administration of a drug product, intended to be sterile, that may contain microbial contamination has the potential to result in serious adverse events which may include life-threatening infections. SCA Pharmaceuticals has not received any customer complaints or reports of adverse events related to this issue.
RECOMMENDATION: SCA Pharmaceuticals is notifying its customers via telephone, email and US mail and is arranging for return/replacement of all recalled products. Customers that have product which is being recalled, as indicated in the list above, should discontinue use immediately and return the product to SCA Pharmaceuticals.
Consumers with questions regarding this recall can contact SCA Pharmaceuticals at 877-550-5059, between the hours of 8:00 am and 5:00 pm (Central Standard Time), Monday thru Friday. 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.
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.
[10/20/2017 - Recall Notice - SCA Pharmaceuticals]