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 Ascorbic Acid, Glutathione, and DMSO Ophthalmic Solution due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling Clotrimazole 2% Otic Suspension due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone 18 mg sterile pellets due to GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Nandrolone Decanoate 250 mg/ml injections due to FDA-identified GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Morphine and Bupivacaine solution due to FDA inspection findings of GMP violations affecting sterility.
The Compounding Pharmacy of America is recalling Estradiol 10 mg Sterile Pellets nationwide due to FDA inspection findings of GMP violations impacting sterility.
The Compounding Pharmacy of America is recalling Morphine and Clonidine solution due to FDA inspection findings of 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 Tri-Mix T-102 Injectable nationwide because an FDA inspection found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling a sterile compounded solution containing morphine, fentanyl, bupivacaine, and clonidine due to FDA-identified GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Morphine 35 mg/ml Solution due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling MIC-B Complex Injectable vials because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Testosterone USP Aqueous 200 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling a sterile morphine and bupivacaine solution because FDA inspections found violations that may affect sterility.
The Compounding Pharmacy of America is recalling Estradiol 22 mg sterile pellets nationwide because FDA inspections found GMP violations that may affect 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 Sermorelin injections due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Hydromorphone, Bupivacaine, and Clonidine intrathecal solution because FDA inspections found GMP violations affecting sterility.
The Compounding Pharmacy of America is recalling HCG 1,200 IU/ml Injection vials due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling Methylcobalamin and Methyl Tetrahydrofolate injectable vials because an FDA inspection found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Zinc Chloride 25mg/ml Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling specific lots of compounded intrathecal solution due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling HCG 4,000 IU/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Estradiol 6 mg sterile pellets nationwide because FDA inspections found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Cholecalciferol 50,000 IU/ml Injectable vials because FDA inspections identified GMP violations that may impact sterility.