Class III · Low risk
Xolegel (ketoconazole)
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Ketoconazole Cream
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-30, UPC 3 0168-0099-30 9.
Affected NDC
0168-0099-30
Compare with the code on your package — it is the most precise check available.
Drug: Ketoconazole
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 |
|---|---|---|---|---|
| ketoconazole NDC 00168-0099 |
20 mg/g | Cream Topical |
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | Rx |
- Recalling firm
- Fougera Pharmaceuticals Inc.
- NDC code
- 0168-0099-30
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1044-2014 · 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 Ketoconazole recalls
See all
Class II · Moderate risk
Ketoconazole Cream
cGMP deviations: Temperature abuse
Class II · Moderate risk
Ketoconazole USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
Reverse Dml Lotion
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
TACROLIMUS 0.1% Ointment and TACROLIMUS 0.1%/KETOCONAZOLE 2%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Other recalls by Fougera Pharmaceuticals Inc.
All 2013 recalls
Class II · Moderate risk
Desonide Ointment
Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream
Class II · Moderate risk
Fluocinonide Gel USP
Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>.
Class III · Low risk
Triamcinolone Acetonide Lotion USP
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Class III · Low risk
Triamcinolone Acetonide Lotion USP
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
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