Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactured for: Piramal Critical Care, Bethlehem, PA 18017, USA, Manufactured by: Sanovel Ilac, San. Ve Tic. A.S. Istanbul, Turkey, NDC 66794-0228-41
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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