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.
Topicort
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.
What was recalled
Topicort (desoximetasone) Topical Spray, 0.25%, 100 mL Bottles, Rx Only. Mfd by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada, L6T 1C1, Dist by: TaroPharma, Hawthorne, NY 10532. NDC: 51672-5281-7.
- Recalling firm
- Taro Pharmaceuticals, Inc.
- Origin
- N/A, Canada
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1370-2015
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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