Class II · Moderate risk Terminated
Desoximetasone Ointment USP
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Desoximetasone Cream USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
What was recalled
Desoximetasone Cream USP, 0.05% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1271-7
- Recalling firm
- Taro Pharmaceuticals, Inc.
- NDC code
- 51672-1271-7
- Origin
- Canada
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0117-2017
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 Desoximetasone recalls
See all
Class II · Moderate risk Terminated
Desoximetasone Ointment USP
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
Desoximetasone Ointment USP
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
Desoximetasone Topical Spray
Reason Failed Impurities/Degradation Specification; high out of specification results observed
Class II · Moderate risk Terminated
Desoximetasone USP
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
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