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Facility that Made Recalled Children's Tylenol, Other Drugs Won't Reopen This Year

Jul 8, 2010 | Parker Waichman LLP

The McNeil Consumer Healthcare manufacturing facility at the center of a massive recall of children’s medicines in April will stay closed until at least the end of the year. McNeil, a unit of Johnson & Johnson, closed the Fort Washington, PA plant in the wake of the recall to address manufacturing issues there.

That April 30 recall included more than 40 varieties of Tylenol Infant Drops, Children’s Tylenol Suspensions, Children’s Tylenol Plus Suspensions, Motrin Infant Drops, Children’s Motrin Suspensions, Children’s Zyrtec Liquid in Bottles, and Children’s Benadryl Allergy Liquid. At the time, the company said some drugs might 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.

That recall was just one of five McNeil has issued for its cold and pain relief products over the past year.

In April, the U.S. Food & Drug Administration (FDA) also cited more than 20 manufacturing problems, including not properly testing for contamination of the recalled products. The problems prompted the FDA to widen its investigation of McNeil’s manufacturing practices, and it is now inspecting the company’s other facilities in Lancaster, PA and Puerto Rico. Officials from the agency have also said they were considering possible criminal charges against Johnson & Johnson and McNeil.

Last month, McNeil issued a statement saying “does not anticipate having sources of supply before the end of 2010 for most of the products that were produced at its Fort Washington, Pa., manufacturing facility.”

“The company is conducting a comprehensive quality assessment across its manufacturing operations and has identified corrective actions that will be implemented before manufacturing resumes at the Fort Washington plant, ” the statement said.

Because of the closure, McNeil’s children’s medicines will not be found in stores. Adult medications also made at Fort Washington, including Benadryl, Motrin, St. Joseph aspirin, Tylenol and Zyrtec will also be impacted.

The FDA said it does not anticipate any medication shortages, however, due to the large number of generic alternatives currently on the market.

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