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 Methylcobalamin 25,000 mcg/ml injections due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling Calmme Injectable multi-dose vials because an FDA inspection identified GMP violations that may 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 Tri-Mix injectable products due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone Cypionate 40 mg/ml injections due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Hyaluronic Acid Sodium and Lidocaine HCl Injection because an FDA inspection found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Hydromorphone, Fentanyl, and Bupivacaine Intrathecal Solution because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Testosterone 12.5 mg sterile pellets due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling Quad-Mix 4 Injectable vials because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Phosphatidylcholine Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling L-Arginine 100 mg/ml Injectable due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling Morphine and Clonidine solution nationwide due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling HCG 1,000 IU/ml Injection kits because an FDA inspection identified 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.
The Compounding Pharmacy of America is recalling Tri-Mix Super Injectable vials because FDA inspections found violations that may affect sterility.
The Compounding Pharmacy of America is recalling Tri-Mix MEDIUM Injectable nationwide due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling Lipovicine Modified II Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Estradiol 8 mg sterile pellets due to GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling a compounded injectable due to GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Tri-Mix T-50 Injectable due to FDA inspection findings of GMP violations that may impact 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 Lipotropic Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Magnesium Sulfate 500 mg/ml Injectable 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 Cyanocobalamin 1,000 mcg/ml multi-dose vials because an FDA inspection identified GMP violations that may impact sterility.