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 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 TriMix compounded injections because the agency could not ensure the products were sterile.
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 TriMix compounded injections because the products may not be sterile. The recall covers vials compounded between May and November 2016.
Tri-Coast Pharmacy is recalling BiMix Phentolamine/Papaverine vials because the agency could not ensure the products were sterile.
Tri-Coast Pharmacy is recalling Quad Mix sterile compounded drug vials due to a lack of assurance of sterility.
Tri-Coast Pharmacy is recalling 278 vials of MIC Ultra Cocktail nationwide due to a lack of assurance of sterility.
Tri-Coast Pharmacy is recalling Sermorelin Acetate 9 mg 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 67 vials of compounded B-Complex injections because the agency cannot assure the products are sterile.
Tri-Coast Pharmacy is recalling 152 vials of compounded Testosterone Cypionate/Propionate because the agency cannot assure the products are sterile.
Tri-Coast Pharmacy is recalling BiMix Phentolamine/Papaverine vials 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 Quad Mix compounded drug vials because the agency could not ensure the products were sterile.
Tri-Coast Pharmacy is recalling 30 vials of compounded Glucosamine 200 mg/mL because the agency cannot assure the products are sterile.
Tri-Coast Pharmacy is recalling 400 vials of compounded Testosterone Cypionate in Sesame because the products lack assurance of sterility.
Tri-Coast Pharmacy is recalling Quad Mix injection vials because the FDA cannot assure the products are sterile. The recall covers vials compounded between May and November 2016.
Tri-Coast Pharmacy is recalling 870 vials of Ultra Amino Energy Cocktail nationwide due to a lack of assurance of sterility.
Tri-Coast Pharmacy is recalling 114 vials of GAC sterile compounded products nationwide due to a lack of assurance of sterility.
Tri-Coast Pharmacy is recalling 5,229 HCG 11,000 IU vials nationwide because the FDA cannot ensure the products are sterile.
Tri-Coast Pharmacy is recalling 7,168 vials of compounded Testosterone Cypionate in Sesame Oil because the FDA determined there was a lack of assurance of sterility.
Tri-Coast Pharmacy is recalling 17 vials of TriMix injection because the agency cannot assure the product's sterility. The recall covers products compounded between May and November 2016.
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 1,544 vials of compounded Testosterone Cypionate/Zinc Gluconate in Sesame Oil nationwide due to a lack of assurance of sterility.
Tri-Coast Pharmacy is recalling 1,567 vials of compounded Testosterone Enanthate in Sesame Oil due to a lack of assurance of sterility.
Tri-Coast Pharmacy is recalling 2,818 vials of compounded Testosterone Cypionate in Grapeseed nationwide due to a lack of assurance of sterility.