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 Morphine and Fentanyl solution due to FDA inspection findings of GMP violations that may 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 compounded intrathecal solutions due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Cholecalciferol 600,000 IU/ml Injectable due to GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling HCG 1,100 IU/ml Injection vials because FDA inspections found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Hydromorphone and Bupivacaine solution because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Tri-Mix injectable products due to FDA inspection findings of GMP violations that impact 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 Lipotropic B-12 II + Lidocaine Injection due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling Dexpanthenol 250 mg/ml Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Hydromorphone 0.25 mg/ml Intrathecal Solution because an FDA inspection found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Tri-Mix SUPER injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Selenium 200 mcg/ml Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Hydromorphone and Bupivacaine solution because an FDA inspection found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Oxytocin 100 units/ml Injection due to FDA-identified GMP violations that may impact sterility and product quality.
The Compounding Pharmacy of America is recalling Fentanyl and Clonidine Intrathecal Solution because an FDA inspection found GMP violations that may have compromised the product's sterility.
The Compounding Pharmacy of America is recalling Hydromorphone 10 mg/ml Intrathecal Solution because FDA inspections found GMP 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 a sterile morphine, bupivacaine, and clonidine solution because an FDA inspection found violations that may affect sterility.
The Compounding Pharmacy of America is recalling Quad-Mix 2 Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling HCG 3,000 IU/ml injections because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Sermorelin 1000 mcg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling TRI-MIX injectable vials because FDA inspections found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling SUPER LIPO Injectable due to FDA inspection findings of GMP violations that may 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.