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 Vitamin K Oxide 5% because it lacks assurance of sterility and has CGMP deviations.
Synergy Rx is recalling Hydroquinone 28% Solution because it may not be sterile. The recall covers all lots distributed nationwide.
Synergy Rx is recalling LTP (Lidocaine 10%, Tetracaine 2%, Phenylephrine 0.5%) ophthalmic solution nationwide due to lack of assurance of sterility and CGMP deviations.
Synergy Rx is recalling DUO Cream because the product lacks assurance of sterility and has CGMP deviations. The recall covers all lots distributed nationwide.
Synergy Rx is recalling all lots of Tacrolimus 0.1% Ointment and Tacrolimus 0.1%/Ketoconazole 2% due to lack of assurance of sterility and CGMP deviations.
Synergy Rx is recalling Enhanced Retin Anti-Wrinkle Cream due to lack of assurance of sterility and CGMP deviations.
Synergy Rx is recalling Supreme Bleaching Cream due to a lack of assurance of sterility and 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 Betamethasone 0.25% cream because it may not be sterile. The recall covers all lots distributed nationwide.
Synergy Rx is recalling Benzoyl Peroxide 5% Clindamycin 1.2% due to lack of assurance of sterility and CGMP deviations.
Synergy Rx is recalling Bicarbonate 10% because the product lacks assurance of sterility and has CGMP deviations.
Synergy Rx is recalling LP Cream (Lidocaine 15%/Prilocaine 5%) because the product lacks assurance of sterility and has CGMP deviations.
Synergy Rx is recalling various betamethasone cream and ointment products due to a lack of assurance of sterility and 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 Hydroquinone Cream in all strengths due to a lack of assurance of sterility and 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 Diclofenac Lip Balm products because they may not be sterile. The recall covers all lots distributed nationwide.
Synergy Rx is recalling all lots of Ketoconazole 2%/Hydrocortisone 1.5% Cream because the product lacks assurance of sterility and has 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 Rosacea Cream because the product lacks assurance of sterility and has CGMP deviations.
Synergy Rx is recalling all lots of CLEAR (Benzoyl Peroxide 3.75%, Clindamycin 1.2% Gel) due to a lack of assurance of sterility and CGMP deviations.
Synergy Rx is recalling TRI-BLEACHING CREAM because it lacks assurance of sterility and has CGMP deviations. The product is distributed nationwide.
Synergy Rx is recalling Clobetasol 0.05% products because the FDA identified 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 HI-LITE Cream because the product lacks assurance of sterility and has CGMP deviations.