FDA (Drugs) recall action 82106
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.
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.
McDaniel Life-Line LLC is voluntarily recalling Life-Line Catalytic Activated Energy Water because it is an unapproved new drug. The product was distributed in the US and several international countries.
McDaniel Life-Line LLC is voluntarily recalling 150 vials of Indian Herb Paste because the product is an unapproved new drug. The recall covers distribution in the US, Italy, Australia, Canada, and Poland.