Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC.
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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