FDA (Drugs) recall action 98494
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.
Stability Data Does Not Support Expiry Date.
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.
HTO Nevada, trading as Kirkman, is recalling Five-Star Vasocaine Spray because the stability data does not support the labeled expiry date.
HTO Nevada, trading as Kirkman, is recalling one lot of Maximum Zone 2 4% Lidocaine Cream because the stability data does not support the labeled expiry date.
HTO Nevada, trading as Kirkman, is recalling one lot of Maximum Zone 1 4% Lidocaine Cream because the stability data does not support the labeled expiry date.