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 1,244 vials of compounded Testosterone Cypionate in Sesame Oil nationwide due to a lack of assurance of sterility.
Tri-Coast Pharmacy is recalling 99 vials of compounded Methylcobalamin/Folic Acid/Pyridoxine injections due to a lack of assurance of sterility.
Tri-Coast Pharmacy is recalling 201 vials of compounded Ascorbic Acid 500 mg/mL due to a lack of assurance of sterility.
Tri-Coast Pharmacy is recalling 161 vials of Infuvite IV compounded between May and November 2016 because the agency cannot assure the products are sterile.
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.