Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.
Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Reason cGMP deviations: Temperature abuse
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of…
Reason Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
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