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 injectable vials because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Tri-Mix ST9C Injectable nationwide due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Estradiol 15 mg sterile pellets nationwide because FDA inspections identified GMP violations affecting sterility.
The Compounding Pharmacy of America is recalling Tri-Mix injectable products because an FDA inspection found violations that may affect 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.
The Compounding Pharmacy of America is recalling Hydroxocobalamin 1,000 mcg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone 200 mg Anastrazole 1 mg Pellets due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Morphine and Bupivacaine Solution due to FDA inspection findings regarding GMP violations and lack of sterility assurance.
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 LIPOLEAN + Ascorbic Acid injectable vials due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling Methionine, Inositol, and Choline injectable vials because FDA inspections found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling a specific intrathecal solution because an FDA inspection found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Lipoderm Modified Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Polidocanol 1% Injection due to FDA inspection findings of GMP violations that may impact sterility.
The FDA is recalling a compounded intrathecal solution from The Compounding Pharmacy of America due to GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Fentanyl and Bupivacaine intrathecal solution because an FDA inspection found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Hydromorphone and Bupivacaine solution due to FDA inspection findings of GMP violations that impact sterility assurance.
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 Alprostadil 100 mcg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Sodium Ascorbate 500 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone Tri-Blend injections due to FDA inspection findings regarding sterility assurance and GMP violations.
The Compounding Pharmacy of America is recalling Testosterone 60 mg Anastrazole 4 mg Pellets because an FDA inspection found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling HCG 500 IU/ml Injection vials because FDA inspections found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Morphine 33 mg/ml Solution due to FDA inspection findings regarding sterility assurance.
The Compounding Pharmacy of America is recalling Fentanyl and Bupivacaine Intrathecal Solution due to GMP violations that may impact sterility.