The government is taking over three Tylenol plants following a blizzard of drug recalls and a Food and Drug Administration criminal investigation into safety issues at the factories.

The FDA and the Justice Department on Thursday took action against McNeil PPC and two of its executives — its vice president of quality and its vice president of operations for over-the-counter products — for failing to comply with federally-mandated manufacturing practice.

McNeil, a division of Johnson & Johnson, said it had agreed to put its plants — one in Las Piedras, Puerto Rico, one in Fort Washington, Pa. and one in Lancaster, Pa., under FDA supervision.

The agreement, known as a “consent decree,” is subject to approval by a federal judge in Pennsylvania.

The decree requires McNeil to adhere to a strict timetable to bring those facilities into compliance.

McNeil also must retain an independent expert to inspect the three plants to determine whether the violations have been corrected, and to ensure that adequate manufacturing processes are in place. After expert certification, the FDA will determine if the facilities are in compliance.

“This is a strong, but necessary, step to ensure that the products manufactured by this company meet federal standards for quality, safety and purity,” said Deborah Autor, director of the Office of Compliance with the FDA.

If McNeil and the executives violate the decree, the FDA may order McNeil to cease manufacturing, recall products and take other corrective action, including levying fines of $15,000 for each day and an additional $15,000 for each violation of the law.

The fines can total up to $10 million annually.

The agreement also requires McNeil to destroy all drugs under its control that have been recalled from the three facilities since December 2009.

McNeil’s drugmaking plants have come under intense scrutiny over the past year after successive recalls in 2010 of over-the-counter pain and cold medicines such as Tylenol, Benadryl and Motrin produced at those facilities.

The company shut its Fort Washington plant following a scathing FDA inspection report of the factory last May that cited 20 manufacturing violations.

That facility makes all of McNeil pediatric over-the-counter Tylenol, Benadryl and Motrin medicines. The other two facilities make adult medicines, including Tylenol.

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