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 and Methylcobalamin injections due to FDA inspection findings of GMP violations that may impact 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 Vitatrim Injection 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 may impact sterility.
The Compounding Pharmacy of America is recalling Morphine and Clonidine solution due to FDA inspection findings regarding GMP violations and lack of sterility assurance.
The Compounding Pharmacy of America is recalling Tri-Mix AT-1 Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Tri-Mix ST9A injectable products due to FDA inspection findings of GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling a compounded injection due to FDA-identified GMP violations that impact sterility assurance.
The Compounding Pharmacy of America is recalling Cholecalciferol 500,000 IU/ml Injectable due to GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Sufentanil and Bupivacaine solution because FDA inspections found violations that may have compromised sterility.
The Compounding Pharmacy of America is recalling Tri-Mix T-101 Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Hydromorphone and Clonidine Intrathecal Solution because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Tri-Mix ST9E injectable products because an FDA inspection found violations that may affect 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 70 mg Pellets because an FDA inspection found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling MEGA-BURN Injectable ROCK CREEK because FDA inspections found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling a compounded intrathecal pain medication because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Testosterone 200 mg Anastrazole 9 mg Pellets because an FDA inspection found GMP violations that may affect 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 Tri-Mix MEDIUM injectable products due to FDA inspection findings of GMP violations that impact sterility assurance.
The Compounding Pharmacy of America is recalling Testosterone 87.5 mg Sterile Pellets because FDA inspections identified GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling a sterile solution containing morphine, clonidine, and bupivacaine because an FDA inspection found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Tri-Mix Injectable due to GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling a specific intrathecal pain medication solution because an FDA inspection found violations that could affect the product's sterility.
The Compounding Pharmacy of America is recalling Magnesium Chloride 200 mg/ml Injection due to FDA inspection findings regarding GMP violations and lack of sterility assurance.