The U.S. Food and Drug Administration 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 per vial and 20 mg per vial and rocuronium bromide injection 50 mg/5 mL, 100 mg/10 mL, commonly used to provide muscle relaxation during surgery or mechanical ventilation, usually include a warning statement embossed on the vial cap to identify the product as a paralyzing agent. The following drugs are affected:
Rocuronium bromide injection by Gland Pharma Limited and Mylan Institutional LLC:
- 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 Limited and distributed by Fresenius Kabi:
- NDC 63323-781-21
- NDC 63323-782-23
The “paralyzing agent” warning statement assists health care professionals in clearly identifying neuromuscular blocking agents that produce muscle paralysis (including the muscles associated with breathing), and can cause significant patient harm, including death, when used in error. These statements are required on the container closure under the FDA approval for these drugs.
During the COVID- 19 pandemic, there has been 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.
As a temporary measure, to increase supply of these drugs, the agency is not objecting to 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 table below provides example images of the vial cap with the “paralyzing agent” warning statement, and the temporary cap without the statement.
Example images of the approved cap (left) and temporary cap (right) for vecuronium bromide for injection.
Example images of the approved cap (left) and temporary cap (right) for rocuronium bromide injection.
The absence of the “paralyzing agent” warning statement on the vial cap may cause the vial to look like another medication when stored upright in a cabinet drawer or on a shelf next to each other. Careful handling of these neuromuscular blocking agents 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.
Vecuronium bromide for injection and rocuronium bromide injection also currently include a prominent “Paralyzing Agent” warning statement (in red bold font) on the container labeling and this will remain on the vials.
FDA encourages health care professionals and patients to report adverse events, medication errors, and quality problems experienced with the use of any medical product to FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178