FDA (Drugs) recall action 82615
The FDA (Drugs) publishes a recall like this one as 10 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 10 pages.
Lack of assurance of sterility for injectables and solutions intended to be sterile.
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.
Customceutical Compounding is recalling specific lots of compounded Glutathione 200mg/mL injection vials because the FDA could not ensure the products were sterile.
Customceutical Compounding is recalling 16 vials of Lipoplex injectable compound because the sterility of the product cannot be assured.
Customceutical Compounding is recalling 8 vials of Test D compounded injectable due to a lack of assurance of sterility. The product was distributed nationwide.
Customceutical Compounding is recalling 32 vials of BPlex injectable compound because the product lacks assurance of sterility. The recall covers products distributed nationwide.
Customceutical Compounding is recalling Test D vials because the manufacturer cannot ensure the injectable solution is sterile.
Customceutical Compounding is recalling 19 vials of BPlex injectable compound due to a lack of assurance of sterility. The product was distributed nationwide.
Customceutical Compounding is recalling Trimix HIGH injectable vials because the company cannot ensure the product is sterile. The recall covers 3 vials distributed nationwide.
Customceutical Compounding is recalling 12 vials of compounded HCG injection due to a lack of assurance of sterility. The product was distributed nationwide.
Customceutical Compounding is recalling Test PROCYP injectable vials because the company cannot guarantee the product is sterile.
Customceutical Compounding is recalling TriMix MEDIUM injectable compound due to a lack of assurance of sterility. The product was distributed nationwide.