FDA (Drugs) recall action 49085
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: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of sildenafil. Sildenafil is the active ingredient in an FDA-approved product indicated for the treatment of male erectile dysfunction (ED), making this product 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.
Chang Kwung Products is recalling Lightning ROD capsules because FDA analysis found an undeclared analogue of sildenafil, an unapproved new drug.
Chang Kwung Products is recalling Lightning ROD capsules because FDA analysis found an undeclared analogue of sildenafil, making the product an unapproved new drug.