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 Pellet 50mg units after receiving seven reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy is recalling 9 units of Betamethasone 6.5mg 10ml vials after seven reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy is recalling compounded preservative-free methylprednisolone 80mg/ml 10 ml vials after seven reports of skin abscesses.
Main Street Family Pharmacy, LLC is recalling 6 units of Lipotropic 2ml PFS due to reports of skin abscesses linked to a related compounded product.
Main Street Compounding Pharmacy is recalling Testosterone Cypionate 300mg/ml vials due to adverse reactions reported for a different compounded product.
Main Street Family Pharmacy is recalling Estradiol Pellets 10mg due to reports of adverse reactions linked to a different compounded product.
Main Street Family Pharmacy is recalling 10 units of Methylprednisolone 80mg SDV vials after seven reports of skin abscesses.
Main Street Family Pharmacy is recalling Lidocaine 1% 30ml vials due to adverse reactions reported for a different compounded product.
Main Street Family Pharmacy is recalling Triamcinolone PF 40mg 2ml vials due to reports of skin abscesses linked to a related compounded product.
Main Street Family Pharmacy is recalling Estradiol Pellets 12.5mg after receiving reports of skin abscesses linked to a different 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 Let Gel after seven reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy, LLC is recalling Pre-menopausal HCG packs due to adverse reactions reported with a different compounded product.
Main Street Family Pharmacy is recalling 147 units of Lipotropic 1ml PFS following seven reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy, LLC is recalling HCG and methylprednisolone products due to reports of skin abscesses.
Main Street Family Pharmacy, LLC is recalling HCG 60 iu prefilled syringes due to adverse reactions reported for a different compounded 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 Betamethasone 7mg after receiving seven reports of skin abscesses potentially linked to the product.
Main Street Compounding Pharmacy is recalling Mic Ultra 50ml Sulfur Free due to reports of skin abscesses linked to compounded methylprednisolone.
Main Street Compounding Pharmacy is recalling Triamcinolone Diacetate 40mg 2ml PF vials after receiving seven reports of skin abscesses.
Main Street Family Pharmacy, LLC is recalling 20 units of Testosterone Cypionate w/lidocaine 10ml due to reports of skin abscesses linked to a different compounded product.
Main Street Compounding Pharmacy is recalling compounded preservative-free methylprednisolone vials after receiving seven reports of skin abscesses.
Main Street Family Pharmacy is recalling compounded methylprednisolone vials after receiving seven reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy is recalling 407 units of Testosterone 200mg, 10ml vials due to adverse reactions reported in a related product.
Main Street Family Pharmacy is recalling 313 units of Medroxyprogesterone 150mg vials after receiving seven reports of skin abscesses.