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 Tri-Mix T-105 Injectable 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 Folic Acid 5 mg/ml Injection due to FDA inspection findings of GMP violations impacting sterility.
The Compounding Pharmacy of America is recalling Fentanyl 1,000 mcg/ml Intrathecal Solution because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling a sterile morphine, fentanyl, and bupivacaine solution because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Tri-Mix Injectable due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling Tri-Mix injectable products due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Hydroxocobalamin and Folic Acid injectable vials due to FDA-identified GMP violations affecting sterility.
The Compounding Pharmacy of America is recalling Tri-Mix injectable products because FDA inspections found GMP violations that may affect sterility.
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 Collagenase 250 units/ml vials because FDA inspections found GMP violations that may affect 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 MEGA-BURN injectable vials because FDA inspections found 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 Hydroxyprogesterone Caproate injectable vials because FDA inspections found GMP violations that may compromise sterility.
The Compounding Pharmacy of America is recalling a sterile, preservative-free compounded solution containing morphine, fentanyl, bupivacaine, and clonidine due to GMP violations affecting sterility assurance.
The Compounding Pharmacy of America is recalling Morphine and Bupivacaine Solution due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling HCG and Methylcobalamin injections due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone 75 mg and B12 6 mg Pellets due to FDA inspection findings regarding sterility assurance.
The Compounding Pharmacy of America is recalling Hydromorphone 12.5 mg/ml Solution due to FDA inspection findings regarding GMP violations and lack of sterility assurance.
The Compounding Pharmacy of America is recalling PGE 150 (Alprostadil) due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling LIPO-VITE Injection vials because an FDA inspection found GMP violations that may affect 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 Morphine and Bupivacaine solution because FDA inspections found violations that may affect sterility.
The Compounding Pharmacy of America is recalling Acetyl-L-Carnitine 250 mg/ml Injectable vials because FDA inspections identified GMP violations that may impact sterility.