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 17 units of Dexamethasone 8mg 10ml after receiving seven reports of skin abscesses linked to a similar compounded product.
Main Street Family Pharmacy is recalling Estradiol Pellets 15mg after receiving reports of skin abscesses linked to a different compounded product.
Main Street Family Pharmacy is recalling HCG 2000IU vials due to reports of skin abscesses linked to a different compounded product.
Main Street Family Pharmacy, LLC is recalling HCG 270 iu prefilled syringes due to reports of skin abscesses linked to a different compounded product.
Main Street Compounding Pharmacy is recalling dexamethasone sodium phosphate vials due to reports of skin abscesses linked to a similar compounded product.
Main Street Family Pharmacy is recalling 23 units of Lipo C injections after receiving seven reports of skin abscesses potentially linked to the product.
Main Street Compounding Pharmacy is recalling Carnitine 250mg/ml vials due to reports of skin abscesses linked to a different compounded product.
Main Street Family Pharmacy, LLC is recalling 20 units of Betamethasone Na phosphate 4mg/ml 10ml vials due to adverse reaction reports.
Main Street Compounding Pharmacy is recalling Lidocaine 2% 30ml vials due to adverse reactions reported for a different compounded product.
Main Street Family Pharmacy is recalling 712 units of Sodium Hyaluronate 2ml vials after receiving seven reports of skin abscesses.
Main Street Family Pharmacy, LLC is recalling 701 units of Testosterone Pellets 50mg due to adverse reactions reported in connection with a separate compounded product.
Main Street Family Pharmacy is recalling B-12/Adenosine 10ml vials due to reports of skin abscesses linked to a different compounded product.
Main Street Compounding Pharmacy is recalling 35 units of B-Complex 100 30ml (PF) after receiving seven reports of skin abscesses.
Main Street Compounding Pharmacy is recalling TCA 30% vials due to adverse reactions reported for a different compounded product.
Main Street Family Pharmacy is recalling 19 units of compounded Glutathione after receiving seven 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 165 units of HCG 275 iu prefilled syringes due to adverse reactions reported for a different compounded product.
Main Street Family Pharmacy is recalling Pre-Menopausal Pack 3rd Month units due to reports of skin abscesses potentially linked to compounded methylprednisolone.
Main Street Compounding Pharmacy is recalling Oral B-12 30ml cotton candy flavor after reports of skin abscesses linked to a related compounded product.
Main Street Compounding Pharmacy is recalling B-12 PFS vials due to reports of skin abscesses linked to a related compounded product.
Main Street Family Pharmacy is recalling Taper Pack C after seven reports of skin abscesses potentially linked to the product.
Main Street Compounding Pharmacy is recalling Dexamethasone LA 16mg 30ml vials after reports of skin abscesses linked to a related compounded product.
Main Street Family Pharmacy is recalling 489 units of Post-menopausal HCG packs nationwide due to reports of skin abscesses linked to a related compounded product.
Main Street Compounding Pharmacy is recalling 1,131 units of Medroxyprogesterone 150mg 1ml vials after receiving seven reports of skin abscesses.
Main Street Family Pharmacy is recalling 50 units of Wydase 5ml because the product lacks assurance of sterility. The recall covers units distributed nationwide prior to and including May 23, 2013.