FDA (Drugs) recall action 65772
The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.
Marketed without an Approved NDA/ANDA; product found to contain dimethazine which is a steroid and/or steroid-like drug ingredient, making it an unapproved new drug
Marketed without an Approved NDA/ANDA; product contains the steroid ingredient 2, 17a-dimethyl-17b-hydroxy-5a-androst-1-en-3-one, making it an unapproved new drug
Marketed without an Approved NDA/ANDA; product found to contain methasterone and dimethazine which are steroid and/or steroid-like drug ingredients, making it an unapproved new drug
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.
Mira Health Products Ltd. is recalling 5,555 bottles of Metha-Drol Extreme capsules because the product contains an unapproved steroid ingredient.
Mira Health Products Ltd. is recalling Super-DMZ Rx 2.0 Capsules because the product contains an unapproved steroid ingredient and was marketed without FDA approval.
Mira Health Products Ltd. is recalling B-50 capsules because they contain unapproved steroid ingredients, making them unapproved new drugs.