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 Sermorelin 6mg vials after seven reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy is recalling Medroxyprogesterone 150mg 10ml vials after receiving seven reports of skin abscesses linked to the product.
Main Street Family Pharmacy is recalling compounded preservative-free methylprednisolone vials after receiving seven reports of skin abscesses.
Main Street Compounding Pharmacy is recalling Test Cypionate 20mg/ml 5ml vials after receiving seven reports of skin abscesses.
Main Street Family Pharmacy, LLC is recalling 604 units of HCG 390iu prefilled syringes due to adverse reaction reports.
Main Street Family Pharmacy is recalling HCG 2500u vials after receiving seven reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy, LLC is recalling 15 units of compounded Cyclosporine Drops due to adverse reactions reported for a different compounded product.
Main Street Family Pharmacy is recalling Alprostadil 100mcg/ml 10ml vials after receiving reports of skin abscesses linked to a different compounded product.
Main Street Family Pharmacy, LLC is recalling HCG 140 iu prefilled syringes due to reports of adverse reactions linked to compounded preservative-free methylprednisolone.
Main Street Family Pharmacy is recalling compounded preservative-free methylprednisolone vials due to reports of skin abscesses.
Main Street Family Pharmacy is recalling compounded methylprednisolone vials after seven reports of skin abscesses.
Main Street Family Pharmacy is recalling compounded preservative-free methylprednisolone 80mg/ml 10 ml vials due to seven reports of skin abscesses.
Main Street Family Pharmacy, LLC is recalling Gomenol 10ml vials after seven reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy, LLC is recalling 24 units of Sodium Hyaluronate 6ml vials due to adverse reactions reported for a different compounded product.
Main Street Family Pharmacy is recalling 20 units of compounded methylprednisolone 40mg PF 2ml after seven reports of skin abscesses.
Main Street Family Pharmacy, LLC is recalling HCG 340 iu prefilled syringes due to adverse reactions reported for a different compounded product.
Main Street Family Pharmacy is recalling B-Complex 206 mg/ml 30ml vials after reports of skin abscesses linked to a different compounded product.
Main Street Compounding Pharmacy is recalling 17-P 1ml vials after seven reports of skin abscesses potentially linked to the product.
Main Street Compounding Pharmacy is recalling Betamethasone 10mg 10ml vials after seven reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy is recalling compounded methylprednisolone vials after receiving seven reports of skin abscesses.
Main Street Family Pharmacy is recalling Testosterone Pellets 75mg after receiving reports of skin abscesses linked to a different compounded product.
Main Street Family Pharmacy is recalling HCG 380 iu prefilled syringes after reports of skin abscesses linked to a related compounded product.
Main Street Compounding Pharmacy is recalling 10 units of Mitomycin 40mg Compounded due to reports of skin abscesses.
Main Street Compounding Pharmacy is recalling Sermorelin GHRP vials after receiving seven reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy, LLC is recalling 22 units of HCG 450 iu prefilled syringes due to adverse reactions reported for a different compounded product.