FDA (Drugs) recall action 76472
The FDA (Drugs) publishes a recall like this one as 81 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 81 pages.
Lack of Assurance of Sterility: There are also CGMP Deviations.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Synergy Rx is recalling Minoxidil and Minoxidil/Retinoic Acid products nationwide due to a lack of assurance of sterility and CGMP deviations.
Synergy Rx is recalling Kojic Acid 8%/Azelaic Acid 15% Cream because it lacks assurance of sterility and has CGMP deviations.
Synergy Rx is recalling Tri-Bleaching Cream because it lacks assurance of sterility and has CGMP deviations.
Synergy Rx is recalling all lots of Reverse DML Lotion because the product lacks assurance of sterility and has CGMP deviations.
Synergy Rx is recalling Bleaching Cream products due to a lack of assurance of sterility and CGMP deviations.
Synergy Rx is recalling various lidocaine cream and ointment products nationwide due to a lack of assurance of sterility and CGMP deviations.
Synergy Rx is recalling Azelaic Acid 15% Cream because the product lacks assurance of sterility and has CGMP deviations.
Synergy Rx is recalling all lots of Jessner's Peel because the product lacks assurance of sterility and has CGMP deviations.
Synergy Rx is recalling Firm and Fade cream because it may not be sterile. The recall covers all lots distributed nationwide.
Synergy Rx is recalling Calming Cream (Hydrocortisone 2.5%) because the product lacks assurance of sterility and has CGMP deviations.
Synergy Rx is recalling all lots of CLEAR 2 (Benzoyl Peroxide 2.5%, Clindamycin 1.2%) because the product lacks assurance of sterility and has CGMP deviations.
Synergy Rx is recalling Betamethasone 0.25% cream because it may not be sterile. The recall covers all lots distributed nationwide.
Synergy Rx is recalling all lots of Retinoic Acid Solution due to a lack of assurance of sterility and CGMP deviations.
Synergy Rx is recalling Erythromycin 2% in CeraVe Cream and Erythromycin 3% / Retinoic Acid 0.05% due to lack of assurance of sterility and CGMP deviations.
Synergy Rx is recalling Quad Bleaching Cream because it lacks assurance of sterility and has CGMP deviations.
Synergy Rx is recalling all lots of HCG products nationwide due to a lack of assurance of sterility and CGMP deviations.
Synergy Rx is recalling HCG and HCG with resveratrol tablets nationwide due to a lack of assurance of sterility and CGMP deviations.
Synergy Rx is recalling QUAD PEEL chemical peels nationwide due to a lack of assurance of sterility and CGMP deviations.
Synergy Rx is recalling specific prescription topical gels and creams because they may lack assurance of sterility and have CGMP deviations.
Synergy Rx is recalling Melatonin 1.5mg Spray because the product lacks assurance of sterility and has CGMP deviations.
Synergy Rx is recalling Gentle Supreme Bleaching Cream because the product lacks assurance of sterility and has CGMP deviations.
Synergy Rx is recalling Custom Lightening/Brightening Cream due to lack of assurance of sterility and CGMP deviations.
Synergy Rx is recalling Rosacea Cream because the product lacks assurance of sterility and has CGMP deviations.
Synergy Rx is recalling RETIN-A 0.05% Cream because of a lack of assurance of sterility and CGMP deviations.
Synergy Rx is recalling Sulfacetamide 10%/Hydrocortisone 1% Cream due to lack of assurance of sterility and CGMP deviations.