McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not administer these products to their children. Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. While the potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue use.
As can be seen, McNeil has cited quality control standards as being the reason for the recall. The buzz in the blogosphere and in the online news outlets references the presence of bacteria in at least one facility. At this point, it appears that the concerns are not as dire as the buzz would like to portray them. In this report from the Associated Press, Deborah Autor, director of the Food and Drug Administration’s drug compliance office, was quoted as stating that the risk, at this point, to consumers was “remote.” What may eventually come of the recall is too hard to predict at this point. However, with the FDA considering additional steps in the investigation, this is definitely an issue that we will need to continue to monitor. A complete list of the products that were involved in the most recent recall can be found here.