WASHINGTON The Food and Drug Administration on Monday posted a media update to its Web page around the most recent McNeil Consumer Healthcare recall, suggesting that the entire McNeil Consumer Healthcare division has come under review.
“FDA is actively pursuing issues related to this recall,” the agency stated. “Drug safety analysts and other medical professionals at FDA have begun a comprehensive review of complaints received by the agency to determine the significance of any adverse events reported and any connection to the use of the recalled products. The FDA is conducting a company-wide investigation of McNeil Consumer Healthcare’s drug manufacturing practices to determine whether similar problems exist throughout the company and what additional steps the agency must take to ensure that these problems do not recur.”
In addition to increased regulatory scrutiny, the House Committee on Oversight and Government Reform on Friday announced it will hold a hearing addressing the latest McNeil recall on May 27 “to examine the circumstances surrounding the voluntary recall of over 40 over-the-counter variations of infant and children’s medicines produced by Johnson & Johnson/McNeil Consumer Healthcare.”
Expected to testify before that panel is Johnson & Johnson chairman and CEO Bill Weldon.
McNeil implemented a voluntary recall of its infant’s and children’s liquid drug products due to manufacturing deficiencies, which may have affected the quality, purity or potency of the drugs on April 30, the FDA noted. McNeil has also ceased production at its Fort Washington, Pa. facility. The agency also reiterated its belief that the chance of serious adverse health consequences associated with the recalled products is remote.