A MedWatch Safety Alert was added to the FDA MedWatch web page.
TOPIC: Two Neuromuscular Blocking Agents: CDER Alert - FDA Alerts Health Care Professionals to the Temporary Absence of Warning Statement on the Vial Caps
AUDIENCE: Health Professional, Pharmacy, Risk Manager
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
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