Vecuronium Bromide for Injection
cGMP deviations: Temperature abuse
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
vecuronium, 10 mg/10mL, (1 mg/mL), 10 mL syringe, Rx only, PARALYZING AGENT, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6012-1.
Compare with the code on your package — it is the most precise check available.
Drug: Vecuronium
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
cGMP deviations: Temperature abuse
Lack of Assurance of Sterility
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.
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Incorrect Product Formulation
Incorrect product formulation: bag did not contain copper and famotidine per label.
Presence of Particulate Matter
Lack of assurance of sterility:
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