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 Tri-Mix Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Morphine 40 mg/ml Solution due to FDA inspection findings of GMP violations that may 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 Vancomycin 25 mg/ml Ophthalmic Solution due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Alprostadil 40 mcg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Hydromorphone and Bupivacaine Intrathecal Solution due to FDA inspection findings of GMP violations that may 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 MEGA-BURN III Injection because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling DMPS injectable vials due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling Estradiol 50 mg sterile pellets because FDA inspections found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling HCG 625 IU/ml Injection kits due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling Hydromorphone 30 mg/ml Solution due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Fentanyl 5,000 mcg/ml Intrathecal Solution due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone 25 mg sterile pellets due to GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling a compounded intrathecal pain solution because an FDA inspection found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling specific compounded injectable vials 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 Testosterone Cypionate 50 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Tri-Mix ST2 Injectable nationwide due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Estradiol 20 mg sterile pellets nationwide because FDA inspections 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 Zinc 5 mg/ml Injectable due to GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Hydromorphone 15 mg/ml Solution because FDA inspections found violations that may affect sterility.
The Compounding Pharmacy of America is recalling Tri-Mix ST1 Injectable due to GMP violations identified by FDA that may impact sterility.
The Compounding Pharmacy of America is recalling Mitomycin 0.03% Ophthalmic Solution due to FDA inspection findings of GMP violations that may impact sterility.