Class II · Moderate risk Terminated
ePHEDrine in 0.9% sodium chloride
Reason Lack of assurance of sterility:
Ephedrine Sulfate Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
What was recalled
Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous Use, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
- Recalling firm
- Akorn, Inc.
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0802-2023
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 Ephedrine recalls
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Class II · Moderate risk Terminated
ePHEDrine in 0.9% sodium chloride
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator
Reason Short Fill
Class III · Low risk Terminated
Allergy Relief D
Reason Failed dissolution specifications
Class II · Moderate risk Terminated
Ephedrine 25 Guaifenesin 200 Tablet
Reason CGMP Deviations
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