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 1,516 units of Lincomycin 300 (PF) 10ml vials due to adverse reactions reported for a different compounded product.
Main Street Family Pharmacy is recalling 20 units of Lipo B Complex 30ml after receiving seven reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy is recalling TCA 30% vials due to reports of skin abscesses linked to a related compounded 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 compounded preservative-free methylprednisolone vials due to reports of skin abscesses.
Main Street Family Pharmacy is recalling 25 units of Aminophylline 25mg/ml 10ml vials due to adverse reaction reports.
Main Street Family Pharmacy, LLC is recalling HCG 300 iu prefilled syringes due to adverse reaction reports linked to a different compounded product.
Main Street Family Pharmacy, LLC is recalling compounded preservative-free methylprednisolone 80mg/ml 10 ml vials due to reports of skin abscesses.
Main Street Family Pharmacy is recalling 4,750 units of HCG 290 iu prefilled syringes due to adverse reaction reports involving skin abscesses.
Main Street Family Pharmacy, LLC is recalling 1,976 units of HCG 240 iu prefilled syringes due to adverse reactions reported with a different compounded product.
Main Street Family Pharmacy, LLC is recalling Methylcob 100mcg/ml 30ml vials after receiving seven reports of skin abscesses potentially linked to the product.
Main Street Family Pharmacy, LLC is recalling AMIC-12 with lido 10ml vials due to reports of skin abscesses.
Main Street Family Pharmacy is recalling Bacteriostatic Water 30ml vials due to seven reports of skin abscesses linked to compounded methylprednisolone.
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 16 units of Testosterone Cypionate 200mg/ml following 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 Lipo B vials after 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 Family Pharmacy, LLC is recalling Alprostadil 40mg units distributed nationwide. The recall follows seven reports of skin abscesses linked to a different compounded product.
Main Street Family Pharmacy is recalling HCG 5,000U vials due to reports of skin abscesses linked to a different compounded product.
Main Street Family Pharmacy is recalling 71 units of Sermorelin 3mg after receiving seven reports of skin abscesses potentially linked to the product.
Main Street Compounding Pharmacy is recalling Double Strength PGE1 40mcg/ml after receiving reports of skin abscesses linked to a related compounded product.
Main Street Family Pharmacy is recalling 4 units of Medroxyprogesterone 150mg due to reports of skin abscesses linked to a related product.
Main Street Family Pharmacy is recalling HCG 10000u vials after reports of skin abscesses linked to compounded methylprednisolone.
Main Street Family Pharmacy is recalling 151 units of Dexamethasone LA 16mg due to reports of skin abscesses linked to a related compounded product.