FDA (Drugs) recall action 77660
The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.
Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
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.
Hardcore Formulations is recalling D-ZINE Rapid Size and Strength capsules because they contain unapproved active ingredients.
Hardcore Formulations is recalling Ultra-Sten capsules because they contain unapproved ingredients and were marketed without an approved NDA or ANDA.