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 B-Complex Injection nationwide because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Lidocaine 1% Injection because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling HCG 2,000 IU/ml Injection vials because FDA inspections found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Methylcobalamin 1,000 mcg/ml Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling HCG 625 IU/ml Injection vials nationwide because an FDA inspection identified GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling MYO-DEN Injection due to FDA inspection findings of GMP violations that may impact sterility and product quality.
The Compounding Pharmacy of America is recalling Testosterone 80 mg Pellets because FDA inspections found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Acetyl-L-Carnitine 500 mg/ml injectable vials because an FDA inspection identified 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 affect sterility and product quality.
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 Hyaluronidase 150 units/ml Injection because an FDA inspection found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling HCG 10,000 IU/ml Injection vials 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 Sermorelin/GHRP6 Injection due to FDA inspection findings of GMP violations that impact sterility assurance.
The Compounding Pharmacy of America is recalling Sermorelin and GHRP-2 injections due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling LIPO-EXTREME Injectable due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling Nandrolone Decanoate 200 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Buckshot Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Morphine and Bupivacaine solution because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Morphine 25 mg/ml Solution due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling Hydromorphone and Bupivacaine solution because an FDA inspection found violations that may affect sterility.
The Compounding Pharmacy of America is recalling Biotin 10 mg/ml Injectable due to GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Mitomycin Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Hydromorphone 1 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.