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 is recalling 568 Sermorelin Acetate 15 mg Injectable Kits nationwide due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling 469 vials of compounded Testosterone Propionate Injectable because the agency could not ensure the product was sterile.
Wells Pharmacy Network LLC is recalling Alprostadil 20 mcg/mL Injectable vials due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling Sermorelin Acetate/GHRP (6) injectable kits nationwide due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling compounded Testosterone Cypionate in Sesame Oil Injectable vials due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling Sermorelin Acetate/GHRP (2) Injectable Kits because the agency could not ensure the products were sterile.
Wells Pharmacy Network LLC is recalling 157 vials of Ultra-Test Injectable nationwide due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling 5,277 kits of compounded Chorionic Gonadotropin injectable kits nationwide due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling 648 vials of MIC/Chromium/B12(M) Injectable because the agency cannot assure the product is sterile.
Wells Pharmacy Network LLC is recalling NADH injectable compounded in Ocala, FL, due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling 325 vials of Ultra-Test Injectable due to a lack of assurance of sterility. The product was distributed nationwide.
Wells Pharmacy Network LLC is recalling 15 vials of Dexamethasone Sodium Phosphate 200 mg/mL injectable compounded in Ocala, FL, due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling 10 kits of compounded Chorionic Gonadotropin (HCG) injectable kits due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling 1,716 vials of a compounded injectable product nationwide due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling Mitomycin 20 mg kits nationwide due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling Trimix Injectable vials because the agency could not ensure the product was sterile.
Wells Pharmacy Network LLC is recalling 351 vials of Arginine HCl 100 mg/mL Injectable due to a lack of assurance of sterility. The product was distributed nationwide.
Wells Pharmacy is recalling Sermorelin Acetate/GHRP (2) Injectable Kits because the agency could not ensure the product was sterile.
Wells Pharmacy Network LLC is recalling 633 vials of MIC/B12 Injectable due to a lack of assurance of sterility. The affected products were distributed nationwide.
Wells Pharmacy Network LLC is recalling 433 vials of Titan Up Injectable because the product may lack assurance of sterility.
Wells Pharmacy Network LLC is recalling Sermorelin Acetate/GHRP (6) Injectable Kits because the agency could not ensure the products were sterile.
Wells Pharmacy Network LLC is recalling Testosterone Cypionate in Sesame Oil Injectable vials because the product lacks assurance of sterility. The recall covers vials prepared between February 2016 and September 2016.