Class II · Moderate risk Terminated
Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Midazolam Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications
What was recalled
MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05
- Recalling firm
- Fresenius Kabi USA, LLC
- NDC code
- 63323-412-05
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0456-2017
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.
Other Midazolam recalls
See all
Class I · High risk Ongoing
Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL
Reason Presence of Particulate Matter: Silicone
Class II · Moderate risk Terminated
midazolam in dextrose 5%
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
midazolam in dextrose 5%
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk Ongoing
Midazolam Injection
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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