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 Tri-Bleaching Cream because it lacks assurance of sterility and has 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 Ultra Lite Cream (Hydroquinone 8%) due to a lack of assurance of sterility and CGMP deviations.
Synergy Rx is recalling Lactic Acid Solution in all strengths due to a lack of assurance of sterility and CGMP deviations.
Synergy Rx is recalling Modified Jessner Peel due to lack of assurance of sterility and 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 ACNE SOLUTION, a prescription topical medication, due to a lack of assurance of sterility and CGMP deviations.
Synergy Rx is recalling Generic VI Peel products nationwide due to a lack of assurance of sterility and CGMP deviations.
Synergy Rx is recalling Cantharidin 0.7% Solution and Cantharidan/Podophyllum Solution due to lack of assurance of sterility and CGMP deviations.
Synergy Rx is recalling Fluorouracil creams because of a lack of assurance of sterility and CGMP deviations.
Synergy Rx is recalling salicylic acid and 5-FU prescription products due to lack of assurance of sterility and 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 Bleaching Cream products due to a lack of assurance of sterility and CGMP deviations.
Synergy Rx is recalling Gentle Bleaching Cream because the product lacks assurance of sterility and has CGMP deviations.
Synergy Rx is recalling 1,809 vials of Human Chorionic Gonadotropin (HCG) because the product lacks assurance of sterility and has CGMP deviations.
Synergy Rx is recalling TCA Peel Solutions in all strengths due to a lack of assurance of sterility and CGMP deviations.
Synergy Rx is recalling Brightening Cream due to a lack of assurance of sterility and CGMP deviations. The product is distributed nationwide.
Synergy Rx is recalling Malek's Magic Plus prescription cream because it lacks assurance of sterility and has CGMP deviations.
Synergy Rx is recalling Fluorouracil creams due to a lack of assurance of sterility and CGMP deviations.
Synergy Rx is recalling all lots of Purified Water due to a lack of assurance of sterility and CGMP deviations.
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 specific glycolic acid prescription products 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 Kojic Acid 8%/Azelaic Acid 15% Cream because it lacks assurance of sterility and has 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.