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 HCG 5,000 IU/ml injections due to FDA inspection findings regarding sterility assurance and GMP violations.
The Compounding Pharmacy of America is recalling Ascorbic Acid 500 mg/ml Injectable Vials nationwide due to FDA inspection findings regarding GMP violations and lack of sterility assurance.
The Compounding Pharmacy of America is recalling Tri-Mix T-106 Injectable due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling HCG and Hydroxocobalamin injections because an FDA inspection found violations that may affect sterility.
The Compounding Pharmacy of America is recalling HCG 1,100 IU/ml Injection kits because FDA inspections found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Fentanyl 7,000 mcg/ml + Bupivacaine 6 mg/ml + Clonidine 40 mcg/ml Intrathecal Solution due to GMP violations affecting sterility.
The Compounding Pharmacy of America is recalling Pyridoxine Hydrochloride 100 mg/ml Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Hydromorphone 70 mg/ml Solution due to FDA inspection findings regarding GMP violations and lack of sterility assurance.
The Compounding Pharmacy of America is recalling HCG and Methylcobalamin injections due to FDA inspection findings regarding sterility assurance.
The Compounding Pharmacy of America is recalling Morphine and Fentanyl solution 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 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 Progesterone 100 mg/ml Injection due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling Hydromorphone 65 mg/ml Solution due to FDA inspection findings of GMP violations that may impact sterility and quality.
The Compounding Pharmacy of America is recalling Testosterone USP injections due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone 200 mg sterile pellets due to GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Bupivacaine and Baclofen intrathecal solution 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 a sterile morphine, clonidine, and baclofen solution because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Bupivacaine 15 mg/ml Intrathecal Solution due to FDA inspection findings regarding GMP violations and lack of sterility assurance.
The Compounding Pharmacy of America is recalling HCG 1,500 IU/ml Injection vials because an FDA inspection found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone 60 mg sterile pellets nationwide due to FDA inspection findings regarding sterility assurance.
The Compounding Pharmacy of America is recalling MIC-PLUS Carnitine Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Tri-Mix T-50/PGE 2/LIDO 2 0.03/0.18/0.09 Injectable because an FDA inspection identified GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Morphine and Bupivacaine solution due to FDA inspection findings regarding sterility assurance.