FDA (Drugs) recall action 72509
The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
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.
Geritrex Corp is recalling GRx HiCort 25 suppositories because the FDA determined they are unapproved new drugs and misbranded.
Geritrex Corporation is recalling Polyethylene Glycol 3350-GRX Powder 100% jars because the FDA determined they are unapproved new drugs and misbranded.
Geritrex Corporation is recalling Carbo-O-Philic 40 Cream tubes because the FDA determined the product is an unapproved new drug and misbranded.
Geritrex Corp is recalling Carbo-O-Philic 40 Gel because the FDA determined it is an unapproved new drug and misbranded.