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 147 vials of a compounded injectable drug due to a lack of assurance of sterility. The products were distributed nationwide.
Wells Pharmacy Network LLC is recalling QUAD4 injectable vials because the FDA determined there is a lack of assurance of sterility.
Wells Pharmacy Network is recalling Arginine/Citrulline/Ornit+Lido injectable vials due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling 131 kits of Indocyanine Green (P.F.) 15 mg Injectable due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling Trimix Injectable vials because the product may lack assurance of sterility.
Wells Pharmacy Network LLC is recalling Methylcobalamin Injectable kits due to a lack of assurance of sterility. The recall covers kits prepared between February 2016 and September 2016.
Wells Pharmacy Network LLC is recalling specific vials of Trimix Injectable because the agency could not ensure the product was sterile.
Wells Pharmacy Network LLC is recalling 1,250 vials of compounded Testosterone Enanthate Injectable nationwide due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling 203 vials of compounded Testosterone Cypionate/Anastrozole Injectable nationwide due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling 203 kits of compounded Fluorescein/Indocyanine Injectable Kits nationwide due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling Tri 1 (PAP/PHEN/ATROPINE) NR Injectable vials because the product lacks assurance of sterility.
Wells Pharmacy Network LLC is recalling 933 vials of MIC/B-COMP/(M)/CHROM/CARN Injectable 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. The recall covers vials prepared between February 2016 and September 2016.
Wells Pharmacy Network LLC is recalling Sermorelin Acetate/GHRP (2) Injectable Kits nationwide due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling 22 vials of a compounded injectable drug due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling 67 vials of Sodium Bicarbonate, 8.4% Injectable, due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling Sermorelin Acetate/GHRP Injectable Kits nationwide due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling 44 vials of Carnitine-L 250 mg/mL Injectable due to a lack of assurance of sterility. The product was distributed nationwide.
Wells Pharmacy Network LLC is recalling 189 vials of Leucine/Isoleucine/Valine Injectable due to a lack of assurance of sterility. The product was distributed nationwide.
Wells Pharmacy Network LLC is recalling 265 vials of compounded Methylcobalamin 5,000 mcg/mL Injectable because the product lacks assurance of sterility.
Wells Pharmacy Network LLC is recalling specific lots of Trimix with Atropine Injectable because the agency could not ensure the product was sterile.
Wells Pharmacy Network LLC is recalling Sermorelin Acetate/GHRP Injectable Kits nationwide because the agency cannot assure the product is sterile.
Wells Pharmacy Network LLC is recalling 1,968 vials of Phenylephrine HCl Injectable due to a lack of assurance of sterility. The product was distributed nationwide.
Wells Pharmacy is recalling 330 Sermorelin Acetate 28 mg Injectable Kits nationwide due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling Trimix with Atropine Injectable vials due to a lack of assurance of sterility. The recall covers products prepared between February 2016 and September 2016.