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 14 vials of L-Carnitine 250 mg/mL because the products lack assurance of sterility. The recall covers sterile products compounded between May 17, 2016, and November 17, 2016.
Tri-Coast Pharmacy is recalling 265 vials of compounded BCAA solution because the agency cannot ensure the products are sterile.
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 17 vials of Quad Mix compounded sterile drug due to a lack of assurance of sterility. The products were distributed nationwide.
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 Quad Mix compounded injections because the agency could not ensure the products were sterile.
Tri-Coast Pharmacy is recalling 141 vials of TriMix compounded injections nationwide due to a lack of assurance of sterility.
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 874 vials of Ultra Slim Shot compounded between May and November 2016 because the products lack assurance of sterility.
Tri-Coast Pharmacy is recalling 25 vials of TriMix injection because the products lack assurance of sterility. The recall covers products compounded between May and November 2016.
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.
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 13 vials of TriMix compounded injections because the agency could not ensure the products were sterile.
Tri-Coast Pharmacy is recalling 987 vials of compounded Lipotropic injections nationwide because the agency could not ensure the products were sterile.
Tri-Coast Pharmacy is recalling Quad Mix compounded injections because the products may not be sterile. The recall covers vials compounded between May and November 2016.
Tri-Coast Pharmacy is recalling 132 vials of IV Cocktail #2 nationwide due to a lack of assurance of sterility.
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 441 vials of Sermorelin Forte Plus 18 mg because the products lack assurance of sterility. The recall covers sterile products compounded between May 17, 2016, and November 17, 2016.
Tri-Coast Pharmacy is recalling TriMix injections because the products may not be sterile. The recall covers vials compounded between May and November 2016.
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 236 vials of Lipotropic with MIC compounded between May and November 2016 due to a lack of assurance of sterility.
Tri-Coast Pharmacy is recalling 882 vials of compounded testosterone products nationwide due to a lack of assurance of sterility.
Tri-Coast Pharmacy is recalling 12 vials of Calcium Gluconate 10% Injection compounded between May and November 2016 due to a lack of assurance of sterility.
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.