FDA (Drugs) recall action 59001
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: The product is 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.
A B Nutrition, Inc. is recalling 509 bottles of Piracetam Powder marketed as a dietary supplement because it is an unapproved new drug.
A B Nutrition, Inc. is recalling 912 bottles of Aniracetam dietary supplement because it is an unapproved new drug marketed without an approved NDA or ANDA.
A B Nutrition, Inc. is recalling 2,980 bottles of Piracetam dietary supplement because it is an unapproved new drug marketed without an approved NDA or ANDA.