Class III · Low risk
Xolegel (ketoconazole)
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Ketoconazole Shampoo
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent
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
Ketoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for Sandoz Inc., Princeton, NJ --- NDC 0781-7090-04.
Affected NDC
0781-7090-04
Compare with the code on your package — it is the most precise check available.
Drug: Ketoconazole
- Recalling firm
- Tolmar, Inc.
- NDC code
- 0781-7090-04
- Origin
- CO, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-66402-001 · 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 Tolmar, Inc.
All 2013 recalls
Class III · Low risk
Eligard (leuprolide acetate)
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Class II · Moderate risk
Naftifine Hydrochloride Gel
Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
Class II · Moderate risk
Clindamycin and Benzoyl Peroxide Gel
Superpotent Drug
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.