Integrity on the Line

May 1, 2010
FDA pressure leads Johnson & Johnson subsidiary to shut down U.S. drug plant.

McNeil Consumer Healthcare is under fire once again with another product recall and further FDA allegations of serious quality deficiencies in the drugmaker’s manufacturing operations.

On April 30, McNeil recalled all lots of certain over-the-counter Children’s and Infant’s liquid products manufactured at its Fort Washington, Pa., facility and distributed to more than a dozen countries. In the recall notice, McNeil stated that “some of these products may not meet required quality standards.” Specifically, according to the company, “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.”

Days later, the Johnson & Johnson subsidiary suspended production at the U.S. plant and says it will not restart operations until the quality issues are resolved.

This latest recall comes on the heels of an earlier recall of Tylenol Arthritis, Motrin, Rolaids and many other types of over-the-counter drugs issued by McNeil in January. At the time, an FDA inspection of the company’s manufacturing plant in Puerto Rico uncovered serious quality-control problems. McNeil had blamed wood pallets used to ship its products for the musty odor that spurred the January recall.

This time, however, the FDA is accusing the drug manufacturer of failing to reject raw material components containing “known contamination of gram negative organisms.” After inspecting McNeil’s Pennsylvania plant in late April, the FDA concluded that contaminated raw materials “were approved for use to manufacture several finished lots of Children’s and Infant’s Tylenol drug products.”

The FDA also chastised McNeil for allowing warehouse operators and personnel unrestricted access to components and labeling. “Drug components and labeling in unrestricted status were observed stored in the open incoming inspection area in the warehouse, along with materials in quarantined and blocked status,” according to the FDA report. Additionally, the FDA found that McNeil failed to implement error-proofing procedures that would prevent the inadvertent use of the wrong amount of acetaminophen.

McNeil has created a special website — — for consumers who want more information about the recalls.