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, LLC is recalling HCG 340 iu prefilled syringes due to adverse reactions reported for a different compounded product.
Main Street Family Pharmacy, LLC is recalling 543 units of Estradiol Pellets 6mg after receiving reports of skin abscesses.
Main Street Compounding Pharmacy is recalling Carnitine 250mg/ml vials due to reports of skin abscesses linked to a different compounded product.
Main Street Compounding Pharmacy is recalling HCG 180 iu prefilled syringes after receiving reports of skin abscesses linked to compounded methylprednisolone.
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 Lipo X 50ml vials after receiving seven reports of skin abscesses potentially linked to the product.
Main Street Compounding Pharmacy is recalling 744 units of Amikacin 500mg 2ml following reports of adverse reactions.
Main Street Compounding Pharmacy is recalling Sodium Tetradecyl Sulfate 3.0% vials due to reports of skin abscesses linked to a different compounded 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 151 units of compounded Testosterone 210mg 10ml vials due to adverse reactions reported for a related product.
Main Street Family Pharmacy is recalling two units of compounded Betamethasone NA Phosphate vials due to adverse reaction reports.
Main Street Family Pharmacy, LLC is recalling Pre-menopausal HCG packs due to adverse reactions reported with 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 Compounding Pharmacy is recalling 59 units of Lipotonix Plus w/Proc/Chrom after receiving seven reports of skin abscesses potentially linked to the product.
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.
Main Street Family Pharmacy, LLC is recalling AMIC-12 with lido 10ml vials due to reports of skin abscesses.
Main Street Family Pharmacy, LLC is recalling Alprostadil 20mcg/ml 25ml vials after receiving seven reports of skin abscesses.
Main Street Compounding Pharmacy is recalling Special Mic Formula 30ml vials after receiving seven reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy is recalling Carnitine 250mg/ml after receiving seven reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy is recalling 1,250 units of Testosterone Pellets 200mg after receiving seven reports of skin abscesses.
Main Street Family Pharmacy is recalling HCG 2500u vials after receiving seven reports of skin abscesses potentially linked to the product.
Main Street Compounding Pharmacy is recalling Sermorelin GHRP vials after receiving seven reports of skin abscesses potentially linked to the product.
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 22 units of compounded methylprednisolone acetate vials due to reports of skin abscesses.
Main Street Family Pharmacy is recalling Betamethasone 6mg PF 10ml vials after receiving seven reports of skin abscesses potentially linked to the product.