Class II · Moderate risk
Clobetasol Propionate Cream USP
Failed content uniformity specifications.
Clobetasol Propionate Cream USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Content Uniformity Specifications
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761 Dist. by : Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 UPC 351672125837 NDC 51672-1258-3
Affected NDC
51672-1258-03
Compare with the code on your package — it is the most precise check available.
Drug: Clobetasol
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 |
|---|---|---|---|---|
| Clobetasol Propionate NDC 51672-1258 |
.5 mg/g | Cream Topical |
Sun Pharmaceutical Industries, Inc. | Rx |
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- NDC code
- 51672-1258-3
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0249-2018 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Clobetasol recalls
See all
Class II · Moderate risk
Clobetasol Propionate Shampoo
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Clobetasol Propionate Ointment
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Clobetasol Propionate Cream
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class III · Low risk
Clobetasol propionate Cream USP
Subpotent Drug: Low assay result observed during long-term stability testing.
Other recalls by Taro Pharmaceuticals U.S.A., Inc.
All 2017 recalls
Class III · Low risk
Hydrocortisone 1% & Acetic Acid 2% Otic Solution
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Class III · Low risk
Clotrimazole and Betamethasone Dipropionate Cream USP
Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
Class I · High risk
Clobetasol Propionate Ointment USP
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Class II · Moderate risk
Nortriptyline HCl Capsules
CGMP deviations.
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