FDA (Drugs) recall action 97935
The FDA (Drugs) publishes a recall like this one as 13 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 13 pages.
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.
Blossom Pharmaceuticals is recalling 14700 bottles of Globe Clotrimazole Cream USP over current good manufacturing practice deviations.
Blossom Pharmaceuticals is recalling 33000 containers of Globe Zinc Oxide Ointment USP over current good manufacturing practice deviations.
Blossom Pharmaceuticals is recalling 9600 containers of Lanashield Skin Barrier over current good manufacturing practice deviations.
Blossom Pharmaceuticals is recalling 1,560 containers of Dynashield Skin Protectant, 16 oz, over current good manufacturing practice deviations.
Blossom Pharmaceuticals is recalling 912 containers of Nivagen Zinc Oxide Ointment USP 20%, 15 oz, over current good manufacturing practice deviations.
Get Tested International AB is recalling 148 units of its Diabetes HbA1c Test because the product was distributed without premarket approval or clearance.
Blossom Pharmaceuticals is recalling 12150 bottles of Globe Clotrimazole Cream over current good manufacturing practice deviations.
Blossom Pharmaceuticals is recalling 8,184 bottles of Dynagel Moisturizing Wound Hydrogel over current good manufacturing practice deviations.
Blossom Pharmaceuticals is recalling 13536 containers of Nivagen Zinc Oxide Ointment over current good manufacturing practice deviations.
Blossom Pharmaceuticals is recalling 7,920 bottles of Nivagen Zinc Oxide Ointment USP 20%, 1 oz, over current good manufacturing practice deviations.
Blossom Pharmaceuticals is recalling 7,944 containers of Dynashield 4 oz cream over current good manufacturing practice deviations.
Blossom Pharmaceuticals is recalling 2,592 bottles of WeCare Zinc Oxide Ointment, 15 oz, over current good manufacturing practice deviations.
Get Tested International AB is recalling 2 units of its Gut Microbiome Test Mega because the product was distributed without premarket approval or clearance.