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 Compounding Pharmacy is recalling Taper Pack B after receiving seven reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy, LLC is recalling MALE HCG Pk after receiving seven reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy is recalling HCG 220 iu prefilled syringes due to reports of adverse reactions involving skin abscesses.
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 43 units of HCG Nasal Spray due to adverse reaction reports.
Main Street Family Pharmacy is recalling Estradiol Pellets 25mg after receiving reports of skin abscesses linked to a different compounded product.
Main Street Family Pharmacy is recalling compounded preservative-free methylprednisolone vials due to seven reports of skin abscesses.
Main Street Family Pharmacy is recalling Lipo Blast compounded injections due to reports of skin abscesses.
Main Street Family Pharmacy is recalling Sodium Tetradecyl Sulfate 2.0% 30ml vials due to reports of skin abscesses linked to a related compounded product.
Main Street Compounding Pharmacy is recalling Glycolic 70% gel after receiving reports of skin abscesses linked to a different compounded product.
Main Street Family Pharmacy is recalling 15 units of Adenosine Monophosphate due to adverse reaction reports involving a different compounded product.
Main Street Family Pharmacy is recalling 116 units of B-12 prefilled syringes following reports of skin abscesses linked to a related compounded product.
Main Street Family Pharmacy is recalling 8 units of Lipotropic 30ml vials after receiving seven reports of skin abscesses potentially linked to the product.
Main Street Compounding Pharmacy is recalling preservative-free methylprednisolone vials after seven reports of skin abscesses.
Main Street Family Pharmacy is recalling 107 units of Testosterone Pellets 25mg due to adverse reaction reports.
Main Street Family Pharmacy is recalling HCG 3000IU vials after receiving reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy, LLC is recalling HCG 5000iu kits due to adverse reactions reported with a different compounded product.
Main Street Family Pharmacy, LLC is recalling 370 units of Mitomycin 40mg after receiving seven reports of skin abscesses.
Main Street Family Pharmacy is recalling 48 units of Triamcinolone Diacetate 40mg 5ml after receiving reports of skin abscesses.
Main Street Family Pharmacy is recalling 5 units of Calcium Gluconate 2.5% Gel due to adverse reactions reported for a different compounded product.
Main Street Family Pharmacy is recalling Mic B-Complex 30ml vials after receiving seven reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy is recalling HCG 1000iu PFS after receiving reports of skin abscesses linked to a different compounded product.
Main Street Family Pharmacy is recalling compounded preservative-free methylprednisolone vials due to reports of skin abscesses.
Main Street Family Pharmacy, LLC is recalling Testosterone Pellets 100mg after receiving seven reports of skin abscesses potentially linked to the product.