FDA (Drugs) recall action 61256
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 ANDA/NDA: presence of sibutramine
Marketed Without an Approved ANDA/NDA: presence of sildenafil
Marketed Without an Approved ANDA/NDA: presence of sildenafil.
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.
Vitaminbestbuy.com is recalling Japan Weight Loss Blue Capsules because they contain sibutramine, an unapproved drug ingredient.
The FDA is recalling Hard Ten Days Capsules because they contain sildenafil, an unapproved active ingredient. Consumers should stop using the product.
The FDA is recalling Man King Capsules because they contain sildenafil, an unapproved active ingredient. Consumers should stop using the product.