A voluntary December 9 recall of antacid products potentially tainted with metal and wood particles has prompted Rep Darrell E. Issa (R, Calif), chairman of the House Committee on Oversight and Government Reform, to ask the Food and Drug Administration (FDA) for details of its oversight of the manufacturer.
Johnson & Johnson subsidiary McNeil Consumer Healthcare, which issued the recall, said the foreign particles were potentially introduced into the product during the manufacturing process at a third-party manufacturer. Johnson & Johnson has turned to such third-party manufacturers after closure of one of its own plants because of multiple recalls in 2010 of over-the-counter products made at that facility.
Mitka M. Outsourcing Questioned. JAMA. 2011;305(6):553. doi:10.1001/jama.2011.97