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 2 units of Betamethasone 6mg 10ml PF because of seven reports of skin abscesses linked to a related compounded product.
Main Street Family Pharmacy is recalling L-glutamine 30mg/ml vials due to adverse reactions reported for a different compounded product.
Main Street Family Pharmacy is recalling EDTA 3% 30ml vials due to reports of adverse reactions linked to 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 Family Pharmacy is recalling Testosterone Pellets 37.5mg after receiving seven reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy, LLC is recalling 102 units of Mitomycin 20mg following seven reports of skin abscesses.
Main Street Family Pharmacy is recalling 25 units of Calcium Gluconate 10% 50ml vials after reports of skin abscesses linked to a related compounded product.
Main Street Family Pharmacy is recalling compounded preservative-free methylprednisolone 80mg/ml 10 ml vials due to reports of skin abscesses.
Main Street Compounding Pharmacy is recalling HCG 11,000U units after receiving reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy is recalling 3 units of Bi-Mix Papaverine and Phentolamine vials due to adverse reaction reports linked to a related compounded product.
Main Street Family Pharmacy, LLC is recalling HCG 280 iu prefilled syringes due to reports of skin abscesses linked to compounded methylprednisolone.
Main Street Family Pharmacy is recalling G-A-C Amino Cocktail 30ml vials due to reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy is recalling methylprednisolone vials after seven reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy, LLC is recalling Amikacin 250mg/ml 2ml vials after receiving seven reports of skin abscesses.
Main Street Compounding Pharmacy is recalling 5 units of Lipotonix Plus 30ml w/o methion after receiving seven reports of skin abscesses potentially linked to the 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 125mg due to reports of adverse reactions involving skin abscesses.
Main Street Family Pharmacy, LLC is recalling 12 units of Mitomycin C after receiving seven reports of skin abscesses potentially linked to the product.
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 methylprednisolone vials after seven reports of skin abscesses potentially linked to the product.
Main Street Compounding Pharmacy is recalling Betamethasone 6mg 30ml vials after receiving seven reports of skin abscesses potentially linked to the product.
Main Street Compounding Pharmacy is recalling Sermorelin 15mg after receiving reports of skin abscesses linked to a different compounded product.
Main Street Family Pharmacy, LLC is recalling Methylcobalamin 1mg/ml 50ml vials due to adverse reactions reported for a different compounded product.
Main Street Family Pharmacy, LLC is recalling Medroxyprogesterone 150mg PF 1ml vials after receiving seven reports of skin abscesses.
Main Street Compounding Pharmacy is recalling Tetracaine 2% after receiving reports of skin abscesses linked to a different compounded product.