The Food and Drug Administration (FDA) is notifying healthcare professionals regarding the temporary absence of the “paralyzing agent” warning statement on vial caps of vecuronium bromide for injection, 10mg/vial and 20mg/vial, and rocuronium bromide injection, 50mg/5mL and 100mg/10mL.
The affected products include vecuronium bromide injection manufactured by Gland Pharma Limited and distributed by Fresenius Kabi (NDC 63326-0781-21 and NDC 63326-0782-23); and rocuronium bromide injection manufactured by Gland Pharma Limited (NDC 68083-0364-01 and 68083-0365-01) and Mylan Institutional LLC (NDC 67457-0228-05 and 67457-0228-10).
Vecuronium bromide and rocuronium bromide are indicated for use as an adjunct to general anesthesia to facilitate endotracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. These products have seen increased use during the coronavirus disease 2019 (COVID-19) pandemic in intensive care unit patients who require mechanical ventilation.
According to the Agency, the “paralyzing agent” warning statement is required on the container closure to assist healthcare professionals in identifying these products, however, due to the shortage of product components (eg, embossed vial caps) during the pandemic, the Agency is allowing for the temporary absence of the embossed “paralyzing agent” warning statement on the vial cap.
This temporary measure will affect vecuronium bromide vials manufactured from June to September 2020 and rocuronium bromide vials manufactured from June to July 2020. The warning statement will continue to remain visible on the container and vial labeling.
As the absence of this warning may cause the vials to potentially resemble other medications, the FDA is advising the following:
- Add an auxiliary warning label to help distinguish the product as a neuromuscular blocking agent.
- Avoid storing the vials so that only the caps are visible.
- Use barcode scanning when stocking medication cabinets, preparing or administering the products.
- Check the label to ensure the correct product is being used.
- For automated dispensing cabinets, consider hospital protocols to limit access and manage override removals.
Adverse reactions may be reported to the FDA’s MedWatch program.
For more information visit fda.gov.