Class II · Moderate risk Terminated
Hydroquinone/Fluocinolone/Tretonoin/Kojic Acid 4/0.01/0.05/2% Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte…
Reason Lack of Processing Control
KOJIC ACID 8%/AZELAIC ACID 15% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: There are also CGMP Deviations.
What was recalled
KOJIC ACID 8%/AZELAIC ACID 15% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
- Recalling firm
- Synergy Rx
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0602-2017
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Kojic recalls
See all
Class II · Moderate risk Terminated
SUPREME CREAM (Retinoic acid 0.05%, hydroquinone 6%, kojic acid 3%, Alpha Arbutin otc 2%, Azeliac acid 2%), Rx only, Synergy RX…
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
SUPREME BLEACHING CREAM (Retinoic acid 0.05%, hydroquinone 6%, kojic acid 3%, Alpha Arbutin OTC 2%, Azeliac acid OTC 2%), Rx…
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
QUAD BLEACHING CREAM (retinoic acid 0.05%, hydroquinone 6%, kojic aid 3%, hydrocortisone 1%), Rx only, Synergy RX, 4901 Morena…
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
MALEK'S MAGIC PLUS (retinoic acid 0.1%, hydroquinone 6%, kojic acid 3%, hydrocortisone 1%), Rx only, Synergy RX, 4901 Morena Blvd…
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
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