ABSTRACT

DEFINITION OF A RECALL Occasionally, consumer products (including dietary supplements) that are in some way defective or violate the laws administered by the FDA do get onto the market. The best and most expedient way of getting such items off the market again and protect the consuming public is a recall. Although the GMPs are silent on this topic (other than for a mention in the preamble) and therefore nothing is specifically mandated, it is prudent for each firm to be prepared for this event, preferably with a written procedure in place and appropriate training accomplished so that if a recall becomes necessary, it will go smoothly.