Johnson & Johnson subsidiary McNeil Consumer Healthcare pleaded guilty on Tuesday to selling liquid medicine contaminated with metal and agreed to pay $25 million to resolve the case, says the U.S. Department of Justice.
According to court documents, on or about May 1, 2009, McNeil received a complaint from a consumer regarding the presence of “black specks in the liquid on the bottom of the bottle” of Infants’ Tylenol. The foreign material was later identified as nickel/chromium-rich inclusions, which were not intended ingredients in the drug.
In connection with receiving this consumer complaint, McNeil did not initiate or complete a Corrective Action Preventive Action (CAPA) plan, as alleged in the charging document. The documents allege numerous other instances in which McNeil found metal particles in bottles of Infants’ Tylenol at its Fort Washington facility but failed to initiate or complete a CAPA.
In April 2010, McNeil, in consultation with the FDA, announced mass global recalls of certain children's over-the-counter-medicines, including Infants' Tylenol and Children's Motrin, made at its Fort Washington, Pennsylvania plant.
As part of the agreement, McNeil also agreed to further safety measures before reopening its Fort Washington facility.
Read the Corporate Crime Reporter article