Class II · Moderate risk
Desoximetasone Ointment USP
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).
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
Desoximetasone Cream USP, 0.25% 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 51672-1270-7
Affected NDC
51672-1270-07
Compare with the code on your package — it is the most precise check available.
Drug: Desoximetasone
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Desoximetasone NDC 51672-1270 |
2.5 mg/g | Cream Topical |
Sun Pharmaceutical Industries, Inc. | Rx |
- Recalling firm
- Taro Pharmaceuticals, Inc.
- NDC code
- 51672-1270-7
- Origin
- Canada
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0116-2017 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Desoximetasone recalls
See all
Class II · Moderate risk
Desoximetasone Ointment USP
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Desoximetasone Ointment USP
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Desoximetasone Topical Spray
Failed Impurities/Degradation Specification; high out of specification results observed
Class II · Moderate risk
Desoximetasone USP
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Other recalls by Taro Pharmaceuticals, Inc.
All 2016 recalls
Class III · Low risk
Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP
Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Class II · Moderate risk
Desoximetasone Cream USP
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
Class III · Low risk
Topicort (desoximetasone)
Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.
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