Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Recalling firm

Almirall, LLC

NDC code

16110-080-45

Origin

PA, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-1549-2022

Other Ketoconazole recalls

See all

Class II · Moderate risk Terminated Apr 13, 2022

Ketoconazole Cream, 2%, Net Wt 60 grams tube, Rx only, MFG: Nycomed Inc, NDC 0168-0099-60

Reason cGMP deviations: Temperature abuse

Mckesson Medical-Surgical Inc. Corporate Office NDC 0168-0099-60 D-1065-2022

Class II · Moderate risk Terminated Feb 9, 2018

Ketoconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8053-4); b) 100g (NDC 58597-8053-6); c) 500g (NDC…

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…

American Pharmaceutical Ingredients LLC NDC 58597-8053-4 D-0499-2018

Class II · Moderate risk Terminated Feb 10, 2017

REVERSE DML LOTION (Ketoconazole 2%, Metronidazole 2%, sulfacetamide sodium 10%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A…

Reason Lack of Assurance of Sterility: There are also CGMP Deviations.

Synergy Rx D-0570-2017

Class II · Moderate risk Terminated Feb 10, 2017

TACROLIMUS 0.1% Ointment and TACROLIMUS 0.1%/KETOCONAZOLE 2%, Rx only, Synergy Rx, 4901 Morena Blvd #504-A San Diego, CA 92117…

Reason Lack of Assurance of Sterility: There are also CGMP Deviations.

Synergy Rx D-0526-2017

Class II · Moderate risk Terminated Feb 10, 2017

KETOCONAZOLE 2%/HYDROCORTISONE 1.5% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676.

Reason Lack of Assurance of Sterility: There are also CGMP Deviations.

Synergy Rx D-0525-2017