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 1,304 vials of compounded HCG/Hydroxycobalamin 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 50 vials of compounded L-Tyrosine 10 mg/mL because the products lack assurance of sterility.
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 41 vials of compounded L-Arginine HCL 100 mg/mL because there is a lack of assurance of sterility. The products were distributed nationwide.
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.
Tri-Coast Pharmacy is recalling 2,818 vials of compounded Testosterone Cypionate in Grapeseed nationwide due to a lack of assurance of sterility.
Tri-Coast Pharmacy is recalling 78 vials of Tri-Amino sterile compounded products due to a lack of assurance of sterility.
Tri-Coast Pharmacy is recalling 90 vials of compounded Taurine 50 mg/mL because the products lack assurance of sterility.
Tri-Coast Pharmacy is recalling 1,244 vials of compounded Testosterone Cypionate in Sesame Oil nationwide due to a lack of assurance of sterility.
Tri-Coast Pharmacy is recalling 79 vials of Ultra Amino Blend because the FDA determined there is a lack of assurance of sterility for the compounded product.
Tri-Coast Pharmacy is recalling 69 vials of Lipo-C compounded between May and November 2016 because the agency could not ensure the products were 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 Quad Mix compounded drug products because they may not be sterile. The recall covers vials compounded between May and November 2016.
Tri-Coast Pharmacy is recalling Quad Mix compounded drug vials because the agency could not ensure the products were sterile.
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 188 vials of Sermorelin Forte 12 mg because the agency could not ensure the sterile products were free from contamination.
Tri-Coast Pharmacy is recalling BiMix Phentolamine/Papaverine vials because there is a lack of assurance of sterility. The recall covers products compounded between May and November 2016.
Tri-Coast Pharmacy is recalling 662 vials of compounded Vitamin D3 100,000 Unit/mL in olive oil because the agency cannot assure the products are sterile.
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 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 1,458 vials of compounded Methylcobalamin injections nationwide because the products lack 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 367 vials of compounded Glutathione 200 mg/mL nationwide because the products lack assurance of sterility.
Tri-Coast Pharmacy is recalling 13 vials of compounded Testosterone Suspension 100 mg/mL due to a lack of assurance of sterility. The recall covers products compounded between May and November 2016.