FDA (Drugs) recall action 71912
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: presence of undeclared Sulfoaildenafil.
Marketed Without An Approved NDA/ANDA: presence of undeclared Sibutramine and Phenolphthalein.
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.
Blue Square Market, Inc. is recalling KABOOM action strips because they contain undeclared sulfoaildenafil and were marketed without an approved NDA or ANDA.
Blue Square Market, Inc. is recalling LiDa DAIDAIHUA capsules nationwide because they contain undeclared sibutramine and phenolphthalein and were marketed without an approved NDA or ANDA.