Fresenius Kabi USA is recalling one lot of Vecuronium bromide for Injection, 10 mg vials, totaling approximately 35,620 units. This prescription medication, used as an anesthetic paralytic, is being recalled because it failed quality testing for impurities and degradation during a 12-month stability check. Specifically, the test showed an out-of-specification result for a substance known as USP related compound F, which means the drug may not meet safety and purity standards through its labeled shelf life.
The presence of impurities or degradation products beyond established safety limits can potentially lead to unpredictable pharmacological effects or adverse reactions in patients receiving the injection.
Manufacturer credit or refund via pharmacy
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Sources: FDA iRES · Raw API Response
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