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 Dexamethasone LA 16mg/ml 10ml vials after reports of skin abscesses linked to a related compounded product.
Main Street Family Pharmacy is recalling Acetylcystein 10% vials due to adverse reactions reported for a different compounded product.
Main Street Family Pharmacy, LLC is recalling 11 units of Minoxidil 10% 60ml. The recall follows seven reports of skin abscesses linked to a different compounded product.
Main Street Family Pharmacy is recalling HCG 11000u w/B-12 vials due to seven reports of skin abscesses linked to a different compounded product.
Main Street Family Pharmacy, LLC is recalling 415 units of Brompheniramine 10ml due to seven reports of skin abscesses.
Main Street Family Pharmacy is recalling 5 units of Methylcobalamin 30ml following seven reports of skin abscesses linked to a different compounded product.
Main Street Compounding Pharmacy is recalling Lipotropic 10ml with B-12 and L-Carnitine due to reports of skin abscesses linked to a related compounded product.
Main Street Family Pharmacy is recalling Testosterone Pellet 87.5mg units due to seven reports of skin abscesses.
Main Street Family Pharmacy is recalling 7 units of Tri-Mix SS Pap 30mg, Phen 1mg, PGE1 10mcg 10ml vials due to reports of skin abscesses.
Main Street Family Pharmacy is recalling compounded preservative-free methylprednisolone 80mg/ml 10 ml vials due to 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 894 units of Ascorbic Acid 500mg/ml 50ml vials due to adverse reaction reports linked to a related compounded product.
Main Street Family Pharmacy is recalling Lido 2% MPF 2ml vials due to reports of skin abscesses linked to the product.
Main Street Family Pharmacy, LLC is recalling Mic B-Complex 50ml vials after seven reports of skin abscesses potentially linked to the product.
Main Street Compounding Pharmacy is recalling Dexamethasone 8/4 10ml and 30 ml vials after seven reports of skin abscesses linked to a related compounded product.
Main Street Family Pharmacy is recalling Betamethasone 6mg PF 10ml vials after receiving seven reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy is recalling 7 units of B-12 (Methyl) 30ml vials due to reports of skin abscesses linked to a different compounded product.
Main Street Family Pharmacy is recalling Acetylcystein 10% 120ml vials after seven reports of skin abscesses linked to a different compounded product.
Main Street Family Pharmacy is recalling Lipotropic 50ml vials due to seven reports of skin abscesses linked to a related compounded product.
Main Street Family Pharmacy is recalling Single Strength PGE1 20mcg/ml vials after receiving seven reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy is recalling 10 units of compounded methylprednisolone injections after receiving seven reports of skin abscesses.
Main Street Family Pharmacy is recalling HCG 15,000u vials due to reports of skin abscesses linked to compounded methylprednisolone.
Main Street Compounding Pharmacy is recalling 43 units of Medroxyprogesterone (PF) 150mg/10ml after receiving seven reports of skin abscesses.
Main Street Compounding Pharmacy is recalling Lipotonix Plus-Mic B complex due to reports of skin abscesses linked to a related compounded product.
Main Street Family Pharmacy, LLC is recalling HCG 220 iu prefilled syringes due to reports of adverse reactions involving skin abscesses.