Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-090-05
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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