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 Estradiol Cypionate 5mg/ml injectable vials because FDA inspections identified GMP violations that may impact product sterility.
The Compounding Pharmacy of America is recalling Alprostadil 10 mcg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Fentanyl and Clonidine intrathecal solution due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Cholecalciferol 100,000 IU/ml Injectable due to GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Estradiol 50 mg sterile pellets because FDA inspections found 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 Hydroxocobalamin 5,000 mcg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Sermorelin/GHRP6 Injection due to FDA inspection findings of GMP violations that impact sterility assurance.
The Compounding Pharmacy of America is recalling Glutathione 200 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Hydromorphone 70 mg/ml Solution due to FDA inspection findings regarding GMP violations and lack of sterility assurance.
The Compounding Pharmacy of America is recalling HCG 625 IU/ml Injection kits due to FDA inspection findings regarding GMP violations and lack of sterility assurance.
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 Tri-Mix Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Fentanyl 2,000 mcg/ml Intrathecal Solution due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Pyridoxine Hydrochloride 100 mg/ml Injectable due to FDA inspection findings of 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 Morphine 50 mg/ml Solution due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Hydromorphone 65 mg/ml Solution due to FDA inspection findings of GMP violations that may impact sterility and quality.
The Compounding Pharmacy of America is recalling Fentanyl 5,000 mcg/ml Intrathecal Solution due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Tri-Mix T-106/PGE 2 0.1/0.14 Injectable because an FDA inspection found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone Cypionate and Anastrazole Injection due to GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling MIC-B12+B6 Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Estradiol 12.5 mg sterile pellets because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Hydromorphone 20 mg/ml Solution due to FDA inspection findings regarding GMP violations and sterility assurance.
The Compounding Pharmacy of America is recalling Testosterone Enanthate 200 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.