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 Fentanyl and Bupivacaine Intrathecal 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.
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 Estradiol 15 mg sterile pellets nationwide because FDA inspections identified GMP violations affecting 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 Tri-Mix Super Injectable vials because FDA inspections found violations that may affect sterility.
The Compounding Pharmacy of America is recalling Sufentanil and Bupivacaine solution because FDA inspections found violations that may have compromised sterility.
The Compounding Pharmacy of America is recalling PGE 40 (Alprostadil) 40 mcg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling specific lots of compounded intrathecal solution due to FDA inspection findings of GMP violations that may impact 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 Morphine 40 mg/ml Solution due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling a specific intrathecal solution because an FDA inspection found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Tri-Mix injectable products due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling Testosterone 87.5 mg Sterile Pellets because FDA inspections identified GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling compounded intrathecal solution due to FDA inspection findings of GMP violations that impact sterility assurance.
The Compounding Pharmacy of America is recalling Tri-Mix AT-6 Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Acetylcysteine 100 mg/ml Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone USP Aqueous 200 mg/ml Injection 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 regarding sterility assurance.
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 a compounded intrathecal pain medication because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling HCG 1,000 IU/ml + MIC B-12 Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Tri-Mix ST9A injectable products due to FDA inspection findings of GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Morphine 20 mg/ml Solution because FDA inspections found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone Cypionate 100 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.