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 Testosterone 100 mg sterile pellets nationwide because FDA inspections found GMP violations affecting sterility.
The Compounding Pharmacy of America is recalling Mitomycin 0.02% Ophthalmic Solution due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Hydromorphone and Baclofen Intrathecal Solution because an FDA inspection found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Testosterone Bi-Blend and Estradiol Valerate injections due to FDA inspection findings regarding sterility assurance.
The Compounding Pharmacy of America is recalling Testosterone Propionate 100 mg/ml Injection due to FDA inspection findings regarding sterility assurance.
The Compounding Pharmacy of America is recalling Hyaluronic Acid Sodium and Lidocaine HCl Injection due to GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Hydromorphone, Clonidine, and Baclofen intrathecal solution because FDA inspections found GMP violations that may have compromised sterility.
The Compounding Pharmacy of America is recalling Tri-Mix ST9A Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Quad-Mix 1 Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Morphine and Baclofen solution because an FDA inspection found violations that may affect sterility.
The Compounding Pharmacy of America is recalling Cyanocobalamin 10 mg Pellets because an FDA inspection found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Morphine 10 mg/ml Solution due to FDA inspection findings regarding GMP violations and lack of sterility assurance.
The Compounding Pharmacy of America is recalling a compounded intrathecal pain solution because FDA inspections found violations that may have compromised the product's sterility.
The Compounding Pharmacy of America is recalling Baclofen 1,000 mcg/ml Intrathecal Solution due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Sufentanil and Bupivacaine Solution due to FDA inspection findings regarding sterility assurance.
The Compounding Pharmacy of America is recalling Betamethasone Sodium Phosphate injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling HCG 5,000 IU/ml injections due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Sodium Tetradecyl Sulfate 5% Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Cyanocobalamin and B-Complex injections 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 Alprostadil 50 mcg/ml Injection because an FDA inspection found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone Cypionate and Anastrazole injections due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Fentanyl and Clonidine Intrathecal Solution due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Morphine 50 mg/ml Solution due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone 70 mg sterile pellets due to FDA inspection findings of GMP violations that may impact sterility.