FDA (Drugs) recall action 75763
The FDA (Drugs) publishes a recall like this one as 80 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 80 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.
Tri-Coast Pharmacy is recalling 920 vials of compounded Sermorelin GT nationwide due to a lack of assurance of sterility.
Tri-Coast Pharmacy is recalling 2 units of TriMix injection because the agency cannot assure the products are sterile.
Tri-Coast Pharmacy is recalling 166 vials of compounded Testosterone Cypionate in Sesame nationwide due to a lack of assurance of sterility.
Tri-Coast Pharmacy is recalling Myers Cocktail #5 vials nationwide because the agency could not ensure the products were sterile.
Tri-Coast Pharmacy is recalling 123 vials of Ultra Cocktail #2 compounded between May and November 2016 because the agency cannot assure the products are sterile.
Tri-Coast Pharmacy is recalling compounded Pyridoxine HCL 100 mg/ml vials because there is a lack of assurance of sterility.
Tri-Coast Pharmacy is recalling 36 vials of Mineral Mix Schrader because the agency cannot assure the products are sterile. The recall covers products compounded between May and November 2016.
Tri-Coast Pharmacy is recalling 66 vials of Myers Cocktail #4 compounded between May and November 2016 due to a lack of assurance of sterility.
Tri-Coast Pharmacy is recalling 347 vials of compounded Testosterone Propionate 100 mg/mL because the agency cannot ensure the products are sterile.
Tri-Coast Pharmacy is recalling TriMix compounded injections because the agency could not ensure the products were sterile.
Tri-Coast Pharmacy is recalling 1,304 vials of compounded HCG/Hydroxycobalamin nationwide due to a lack of assurance of sterility.
Tri-Coast Pharmacy is recalling 35 vials of TriMix compounded injections because the agency cannot assure the products are sterile.
Tri-Coast Pharmacy is recalling compounded Glutamine 25 mg/mL vials nationwide because the agency cannot assure the products are sterile.
Tri-Coast Pharmacy is recalling 91 vials of Sermorelin Acetate 15 mg compounded between May and November 2016 because the agency cannot assure the products are sterile.
Tri-Coast Pharmacy is recalling Dexpanthenol 250 mg/mL vials because the agency could not ensure the products were sterile.
Tri-Coast Pharmacy is recalling Calm Me compounded sterile products because there is a lack of assurance of sterility. The recall covers 10 vials distributed nationwide.
Tri-Coast Pharmacy is recalling 4,884 vials of HCG 5,000 IU due to a lack of assurance of sterility. The products were distributed nationwide.
Tri-Coast Pharmacy is recalling 105 vials of Amino Acid Recover Eaze because the agency cannot assure the products are sterile.
Tri-Coast Pharmacy is recalling 59 vials of Amino Energy Cocktail because the agency cannot assure the sterility of the compounded product.
Tri-Coast Pharmacy is recalling Sermorelin Forte 6 mg vials because the agency could not ensure the products were sterile.
Tri-Coast Pharmacy is recalling 701 vials of Nandrolone Decanoate 200 mg/ml because the agency could not ensure the products were sterile.
Tri-Coast Pharmacy is recalling 2,116 vials of Sermorelin Forte Plus 27 mg because the products lack assurance of sterility.
Tri-Coast Pharmacy is recalling 17 vials of TriMix injection because the agency could not ensure the products were sterile.
Tri-Coast Pharmacy is recalling 127 vials of Slim Shot compounded between May and November 2016 due to a lack of assurance of sterility.
Tri-Coast Pharmacy is recalling 260 vials of Sermorelin Acetate 6 mg compounded between May and November 2016 because the agency cannot assure the products are sterile.