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 VI PEEL chemical peel products nationwide due to a lack of assurance of sterility and CGMP deviations.
Synergy Rx is recalling Tretinoin 0.02% in Oil Free Cream because of a lack of assurance of sterility and CGMP deviations.
Synergy Rx is recalling specific clindamycin and tretinoin products due to a lack of assurance of sterility and CGMP deviations.
Synergy Rx is recalling all strengths of Glycolic Acid Solution because the product lacks assurance of sterility and has CGMP deviations.
Synergy Rx is recalling Fluocinonide 0.05% Solution due to a lack of assurance of sterility and CGMP deviations.
Synergy Rx is recalling Supreme Cream due to a lack of assurance of sterility and CGMP deviations.