FDA (Drugs) recall action 75289
The FDA (Drugs) publishes a recall like this one as 97 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 97 pages.
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.
Wells Pharmacy Network LLC is recalling 46 kits of compounded Ceftazidime Ophthalmic 2.25% due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling 106 vials of a compounded injectable product due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling compounded Chorionic Gonadotropin+B12(C) Injectable Kits due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling MIC+B12(M)+Carnitine injectable vials due to a lack of assurance of sterility. The recall covers 159 vials distributed nationwide.
Wells Pharmacy Network LLC is recalling Trimix with Atropine Injectable vials because they may lack assurance of sterility. The recall covers products prepared between February 22, 2016, and September 14, 2016.
Wells Pharmacy Network LLC is recalling 21 vials of Testosterone Cypionate in Sesame Oil Injectable due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling Methylcobalamin 1,000 mcg/mL Injectable vials because the agency could not ensure the product was sterile.
Wells Pharmacy Network LLC is recalling 122 syringes of Mitomycin Solution Injectable because the agency could not ensure the product was sterile.
Wells Pharmacy Network LLC is recalling 1,753 kits of compounded Chorionic Gonadotropin injectable kits nationwide due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling Bimix 30 mg/1 mg/mL Injectable vials because the product lacks assurance of sterility.
Wells Pharmacy Network LLC is recalling QUAD3 injectable vials because the FDA determined there is a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling Trimix Injectable vials nationwide due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling Testosterone Cypionate in Grapeseed Oil Injectable vials because the product lacks assurance of sterility.
Wells Pharmacy Network LLC is recalling 199 vials of a compounded injectable product nationwide due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling 2,339 compounded Chorionic Gonadotropin Injectable Kits nationwide due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling 908 compounded Chorionic Gonadotropin Injectable Kits nationwide due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling QUAD2 injectable vials because they may not be sterile. The recall covers vials prepared between February and September 2016.
Wells Pharmacy Network LLC is recalling 37 vials of compounded Alprostadil 40 mcg/mL Injectable due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling 148 vials of Glutathione 200 mg/mL Injectable nationwide due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling 266 vials of compounded Testosterone Cypionate Injectable due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling compounded Chorionic Gonadotropin injectable kits due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling 18 vials of TitanMax-MIC/12/CA/CH/L/D Injectable due to a lack of assurance of sterility. The product was distributed nationwide.
Wells Pharmacy Network LLC is recalling 2,264 Sermorelin Acetate/GHRP (2) Injectable Kits nationwide due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling MIC Combo injectable vials because the agency could not ensure the product was sterile.
Wells Pharmacy Network LLC is recalling 433 vials of LipoLean injectable compounded in Florida due to a lack of assurance of sterility.