FORT WASHINGTON, Pa. In a statement released Tuesday, McNeil Consumer Healthcare stated: “The quality issues that [the Food and Drug Administration] has observed, many of which we had recently identified in our own quality reviews and communicated to the FDA, are unacceptable to us, and not indicative of how McNeil Consumer Healthcare intends to operate.”
McNeil Consumer Healthcare last week voluntarily recalled all lots that have not yet expired of certain over-the-counter children’s and infants’ liquid products in consultation with the Food and Drug Administration. The agency suggested that McNeil’s Fort Washington, Pa. plant may not be compliant with Good Manufacturing Practices.
“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,” the FDA stated on its Web site.
Both the FDA and McNeil suggested the risk for adverse events associated with the recalled products was relatively low.
Following the recall, McNeil has temporarily suspended production at its Fort Washington production facility. “We will not restart operations until we have taken the necessary corrective actions and can assure the quality of products made there,” McNeil stated. “We will continue to work in close consultation with the FDA to take corrective action and ensure that our quality operations meet the high standards that consumers expect from us.”