FDA Alert for Two Neuromuscular Blockade Meds 6-17-20
Executive Summary:
The FDA is reportedly sending healthcare providers notice of temporary approval of a missing ‘Paralyzing Agent’ warning from the caps of vials of certain strengths of two neuromuscular blockade IV medications, namely vecuronium bromide and rocuronium bromide. The affected products, with NDC numbers, manufacturers, and recommendations can be found at the FDA link below.
The missing vial cap warning is important as a safety reminder for a high-risk medication. More complete details can be found in the body of this article.
The FDA is sending healthcare providers notice of a missing ‘Paralyzing Agent’ warning from the caps of vials of certain strengths of two neuromuscular blockade IV medications, namely vecuronium bromide and rocuronium bromide. The affected products, with NDC numbers and manufacturers, as well as recommendations for alternative labeling and handling, can be found at the FDA link below.
This embossed warning is required on the caps, but has been allowed to be temporarily left off as the demand for these drugs has increased dramatically, requiring greater distribution than the current stock of embossed vials would allow. Both issues are due to the COVID Pandemic.
The missing vial cap warning is important as a safety reminder for this high-risk medication, particularly when the med is stored in a vertical format, amongst other meds, and the vial label is not readily seen when selecting a med. Accidently selecting this drug and administering it could have serious adverse effects, including death.
FDA Alert on Missing Warning on Neuromuscular Blockade Medications:
https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-health-care-professionals-temporary-absence-warning-statement-vial-caps-two-neuromuscular
