FDA (Drugs) recall action 71371
The FDA (Drugs) publishes a recall like this one as 382 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 382 pages.
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and 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.
The Compounding Pharmacy of America is recalling HCG 1,000 IU/ml Injection vials due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Bi-Mix #1 Injectable due to FDA inspection findings of GMP violations that impact sterility assurance.
The Compounding Pharmacy of America is recalling Methylcobalamin 4,000 mcg/ml Injectable vials because FDA inspections found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling a sterile compounded solution of morphine, fentanyl, and bupivacaine due to GMP violations that compromise sterility assurance.
The Compounding Pharmacy of America is recalling Estradiol 4 mg sterile pellets because FDA inspections found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone Bi-Blend and Estradiol Valerate injectable due to FDA inspection findings of GMP violations impacting sterility.
The Compounding Pharmacy of America is recalling Hyaluronidase 175 units/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.