Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, SCA Pharmaceuticals…
Reason Lack of Assurance of Sterility
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility
MIDAZOLAM 1MG/ML IN NACL 0.9% INJ SYR C-IV, 55 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0135-55
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
Reason Presence of Particulate Matter: Silicone
Reason Lack of assurance of sterility:
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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