Class II · Moderate risk Ongoing
Albuterol Sulfate Inhalation Solution
Reason Labelling: Illegible label
Albuterol Sulfate Syrup
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
Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, 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-0783-2023
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 Albuterol recalls
See all
Class III · Low risk Ongoing
Albuterol Sulfate
Reason Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
Class II · Moderate risk Ongoing
Airsupra
Reason Defective delivery system
Class II · Moderate risk Terminated
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP
Reason Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Class I · High risk Terminated
Albuterol Sulfate Inhalation Aerosol
Reason Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
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