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 Quad-Mix 1 Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The FDA is recalling compounded morphine, fentanyl, and baclofen injections due to GMP violations that may compromise sterility. The recall covers lots distributed nationwide between November 2014 and May 2015.
The Compounding Pharmacy of America is recalling Cholecalciferol 600,000 IU/ml Injectable due to GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Cyanocobalamin 1,000 mcg/ml multi-dose vials because an FDA inspection identified GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Dexpanthenol 215 mg/ml Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Estradiol Valerate 40 mg/ml injectable vials because FDA inspections found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone 30 mg sterile pellets nationwide because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Polidocanol 5% Injection due to FDA inspection findings of GMP violations that 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 Hyaluronic Acid Sodium and Lidocaine HCl Injection due to GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone Cypionate 40 mg/ml Injectable due to FDA inspection findings regarding sterility assurance.
The Compounding Pharmacy of America is recalling Hydromorphone and Baclofen Intrathecal Solution because an FDA inspection found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling a sterile morphine, clonidine, and baclofen solution because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling HCG 1,250 IU/ml Injection vials because FDA inspections identified GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling HCG 1,100 IU/ml Injection vials because FDA inspections found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Tri-Mix Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling HCG 2,500 IU/ml Injection vials due to GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Tri-Mix Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Morphine 45 mg/ml Solution due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Fentanyl and Bupivacaine intrathecal solution due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone 20 mg sterile pellets due to GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone 70 mg Pellets because an FDA inspection found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Testosterone 60 mg sterile pellets nationwide due to FDA inspection findings regarding sterility assurance.
The Compounding Pharmacy of America is recalling Lipotropic Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling HCG 625 IU/ml Injection kits because an FDA inspection found GMP violations that may affect sterility.