Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to 10 mL, 10 mL Vial (NDC 0703-2914-01), packaged in 10 x 10 mL Vials per tray (NDC 0703-2914-03), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
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 Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Reason Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
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