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 Estradiol 25 mg sterile pellets nationwide due to GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Lidocaine 2% with Epinephrine 1:100,000 vials due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling a compounded intrathecal solution because an FDA inspection found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Polidocanol 5% Injection due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling MEGA-BURN Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone Cypionate 250 mg/ml Injection 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 may impact sterility.
The Compounding Pharmacy of America is recalling Hydroxocobalamin 10,000 mcg/ml 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 vials because FDA inspections found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Tri-Mix Injectable due to FDA inspection findings regarding GMP violations and lack of sterility assurance.
The Compounding Pharmacy of America is recalling HCG 1,000 IU/ml Injection kits nationwide 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 of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Tri-Mix T-106/PGE 2 0.1/0.14 Injectable because an FDA inspection found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Bi-Mix (20/1) Injectable due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling Alprostadil 10 mcg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone Cypionate 200mg/ml Injection 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 Fentanyl and Bupivacaine Intrathecal Solution 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 may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone 75 mg Pellets due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Alprostadil 100 mcg/ml injections due to FDA inspection findings 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 Hydromorphone 20 mg/ml Solution due to FDA inspection findings regarding GMP violations and sterility assurance.
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 Tri-Mix Injectable due to FDA inspection findings of GMP violations that may impact sterility.