Market withdrawal

A market withdrawal is not a recall and is not reported to FDA under 21 CFR 806. Firms should document why the issue counts only as a minor violation, since that reasoning is what separates the action from a reportable correction or removal.

Market withdrawal means a firm's removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the Food and Drug Administration or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc.

21 CFR, 7.3

Market withdrawal means a correction or removal of a distributed device that involves a minor violation of the act that would not be subject to legal action by FDA or that involves no violation of the act, e.g., normal stock rotation practices.

21 CFR, 806.2