Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3321.
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: Leaking/damaged syringes.
Reason cGMP Deviations: Products were stored outside the drug label specifications.
Reason Lack of assurance of sterility:
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
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