Johnson & Johnson Facilities at Center of Tylenol, Other Drug Recalls Face Greater FDA Scrutiny

A Johnson & Johnson drug plant in Fort Washington, Pennsylvania that made millions of bottles of recalled medicine, including <"">Tylenol, Benadryl and Motrin, will not be allowed to reopen until the U.S. Food & Drug Administration (FDA) is assured that it meets quality standards. A proposed consent decree signed by the FDA and Johnson & Johnson would also place two other plants located in Pennsylvania and Puerto Rico, that like the Fort Washington facility are operated by the company’s McNeil Consumer Healthcare Division, under greater federal oversight.

As we’ve reported previously, McNeil has recalled more than 200 million bottles of over-the-counter medicine in the past year or so. Many of the recalled products were made at McNeil’s Fort Washington, Pennsylvania facility, which was temporarily closed last year because of quality issues. The Las Piedras, Puerto Rico plant was the subject of an FDA warning letter last year, while the Lancaster, Pennsylvania facility, which is operated as a joint venture with Merck, was cited for numerous violations last year after an FDA inspection.

Under the consent decree, which still has to be approved by a Judge, McNeil will not be able to open the Fort Washington until an independent expert determines that the plant meets all federal standards and passes an agency inspection. While the Lancaster and Las Piedras facilities will be able to remain open, the decree also requires McNeil to adhere to a strict timetable to bring all three plants into compliance.

The consent decree requires McNeil to destroy all drugs under its control that have been recalled from the Fort Washington, Las Piedras, and Lancaster facilities since December 2009. The decree also gives the agency the authority to require McNeil to stop manufacturing or to institute recalls.

The consent decree also stipulates that McNeil could face fines of $15,000 a day for violating the decree, up to $10 million a year. The decree, which was filed in U.S. District Court for the Eastern District of Pennsylvania in Philadelphia on March 10, will remain in effect for five years.

“This is a strong, but necessary, step to ensure that the products manufactured by this company meet federal standards for quality, safety and purity,” Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said in a statement issued by the FDA.

Overall, it’s been a tough year for Johnson & Johnson, which has been plagued by recalls. Other Johnson & Johnson recalls have involved two DePuy hip replacement implants sold by its DePuy Orthopaedics unit, as well as a recall (an initial action and an expansion) of 100,000 boxes of 1-Day Acuvue TruEye contact lenses. These withdrawals are also weighing on Johnson & Johnson’s performance, as profits for the fourth quarter fell 12 percent.

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