FDA (Drugs) recall action 65479
The FDA (Drugs) publishes a recall like this one as 299 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 299 pages.
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Lack of Assurance of Sterility
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.
Main Street Family Pharmacy is recalling Estradiol Pellets 12mg after receiving reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy, LLC is recalling Testosterone Pellet 112mg due to reports of skin abscesses linked to a different compounded product.
Main Street Family Pharmacy is recalling 4 units of Mitomycin 0.02% following seven reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy, LLC is recalling 10 units of Pontocaine 2% 4 oz following seven reports of skin abscesses.
Main Street Compounding Pharmacy is recalling HCG 5000iu units after receiving seven reports of skin abscesses potentially linked to compounded preservative-free methylprednisolone.
Main Street Family Pharmacy is recalling compounded methylprednisolone vials after seven reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy is recalling compounded methylprednisolone vials after seven reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy, LLC is recalling compounded methylprednisolone vials due to reports of skin abscesses.
Main Street Family Pharmacy is recalling HCG 12000u vials after receiving seven reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy is recalling 32 units of Mitomycin 2ml due to seven reports of skin abscesses.
Main Street Family Pharmacy is recalling HCG 15000u w/b-12 units due to reports of skin abscesses linked to compounded methylprednisolone.
Main Street Family Pharmacy is recalling HCG 230 iu prefilled syringes due to reports of skin abscesses linked to a related compounded product.
Main Street Family Pharmacy is recalling 80 units of Testosterone Propionate 100mg 10ml vials due to reports of skin abscesses.
Main Street Family Pharmacy, LLC is recalling HCG 260 iu prefilled syringes due to reports of adverse reactions linked to compounded methylprednisolone.
Main Street Family Pharmacy is recalling 15 units of B-12 1ml prefilled syringes after receiving seven reports of skin abscesses linked to a different compounded product.
Main Street Family Pharmacy is recalling Lipoden 50ml vials after receiving seven reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy, LLC is recalling HCG 100 iu prefilled syringes due to reports of adverse reactions involving skin abscesses.
Main Street Family Pharmacy is recalling Taper A prefilled syringes due to reports of skin abscesses linked to compounded methylprednisolone.
Main Street Compounding Pharmacy is recalling 19 units of L-Carnitine 30ml after receiving seven reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy, LLC is recalling 54 units of Dexamethasone LA 16mg/ml 30ml. The recall follows seven reports of skin abscesses linked to a different compounded product.
Main Street Compounding Pharmacy is recalling 6 units of Aminophylline 250mg 10ml vials after reports of skin abscesses linked to a related methylprednisolone product.
Main Street Family Pharmacy is recalling Estradiol Pellets 31mg after receiving reports of skin abscesses linked to a different compounded product.
Main Street Compounding Pharmacy is recalling Double Strength PGE1 40mcg 2ml vials due to reports of skin abscesses linked to a related compounded product.
Main Street Family Pharmacy is recalling Triamcinolone Diacetate 40mg 10ml vials after receiving reports of skin abscesses linked to a related compounded product.
Main Street Family Pharmacy is recalling Testosterone Pellet 112.5mg units due to reports of skin abscesses linked to compounded methylprednisolone.