Class II · Moderate risk Ongoing
Clobetasol Propionate Shampoo
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Clobetasol Propionate Ointment
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
Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, 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-0795-2023
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 Clobetasol recalls
See all
Class II · Moderate risk Ongoing
Clobetasol Propionate Cream
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class III · Low risk Terminated
Clobetasol propionate Cream USP
Reason Subpotent Drug: Low assay result observed during long-term stability testing.
Class II · Moderate risk Terminated
Clobetasol Propionate Lotion 0.05%
Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
Class II · Moderate risk Terminated
Clobetasol Propionate Cream USP
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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