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 found to contain methasterone and dimethazine which are steroid and/or steroid-like drug ingredients, 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
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 B-50 capsules because they contain unapproved steroid ingredients, making them unapproved new drugs.
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.