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McNeil, DOJ March 2015 Settlement
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J&J’s McNeil to Pay $25 Million to Settle Probe After Recalls
Mar 10, 2015 | WSJ
By Tess Stynes
Fort Washington, Pa., plant was shut down in 2010 after recalls of liquid medicines made for children -
Tylenol Maker Admits to Selling Liquid Medicine Contaminated with Metal
Mar 11, 2015 | TIME
By Sam Frizell
A Johnson & Johnson subsidiary will pay $25 million after pleading guilty to a federal crime -
Tylenol maker to pay $25 million for selling metal-contaminated drugs
Mar 10, 2015 | Reuters
By Lindsay Dunsmuir
A Johnson & Johnson subsidiary pleaded guilty on Tuesday to selling liquid medicine contaminated with metal and agreed to pay $25 million to resolve the case, the U.S. Department of Justice said on Tuesday. -
Maker of kids' Tylenol pleads guilty over metal particles
Mar 10, 2015 | AP (Yahoo News)
By Michael Rubinkam and MaryClaire Dale
PHILADELPHIA (AP) — A subsidiary of Johnson & Johnson pleaded guilty Tuesday to a federal criminal charge that it sold over-the-counter infant's and children's liquid medicine containing metal particles.
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J&J’s McNeil to Pay $25 Million to Settle Probe After Recalls
Mar 10, 2015 | WSJ
By Tess Stynes
Johnson & Johnson said its McNeil consumer products business agreed to pay $25 million to settle a U.S. government probe into a Pennsylvania plant that recalled Tylenol and other over-the-counter medicines several years ago because of quality lapses.
Under the agreement with the Justice Department, McNeil pleaded guilty to a misdemeanor violation and accepted responsibility for the inadequate filing of required documents during the manufacturing process. McNeil will pay a $20 million criminal fine and forfeit $5 million.
McNeil’s Fort Washington, Pa., plant was shut down in 2010 after it recalled several liquid medicines made for children, including Tylenol, Zyrtec and Benadryl products. It has yet to reopen.
J&J has tried to put behind it a series of recalls that led to increased scrutiny. Problems ranging from excessive concentrations of active ingredients to musty-smelling products spurred the recalls, which hurt sales and damaged J&J’s reputation.
“This plea agreement fully and finally resolves the federal government’s investigation, and closes a chapter on actions that led the company to review and significantly improve its procedures,” said Carol Goodrich, a McNeil spokesperson in a statement. McNeil noted that the recalls weren’t undertaken because of health or safety risks to consumers.
According to the Justice Department, McNeil is working to bring the Fort Washington facility into compliance and aims to open it once it gets clearance from the U.S. Food and Drug Administration. McNeil’s remaining U.S. facilities are open but operating under a 2011 permanent injunction.
The Justice Department had accused McNeil of failing to address repeated complaints about contamination of certain over-the-counter drugs for infants and children.
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Tylenol Maker Admits to Selling Liquid Medicine Contaminated with Metal
Mar 11, 2015 | TIME
By Sam Frizell
The maker of Tylenol pleaded guilty in a Federal Court on Tuesday to selling liquid medicine contaminated with metal.
McNeil Consumer Healthcare, a Johnson & Johnson subsidiary, pleaded guilty in a Federal District Court in Philadelphia to a criminal charge of manufacture and process of adulterated over-the-counter medicines. The company agreed to a $25 million settlement with the U.S. Department of Justice.
The company launched wide-ranging recalls in 2010 of over-the-counter medicines including Infants’ Tylenol and Children’s Motrin.
Those recalls came on the heels of others from 2008 to 2010 that involved hundreds of millions of bottles of Tylenol, Motrin, Benadryl and other consumer products. Metal particles contaminated the liquid medicines, which also suffered from moldy odors and labeling problems.
A spokeswoman for McNeil Consumer Healthcare said the plea agreement “closes a chapter” and that the company has “been implementing enhanced quality and oversight standards across its entire business,” Reuters reports.
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Tylenol maker to pay $25 million for selling metal-contaminated drugs
Mar 10, 2015 | Reuters
By Lindsay Dunsmuir
Johnson & Johnson subsidiary pleaded guilty on Tuesday to selling liquid medicine contaminated with metal and agreed to pay $25 million to resolve the case, the U.S. Department of Justice said on Tuesday.
The subsidiary, McNeil Consumer Healthcare, pleaded guilty to one federal criminal charge in the case.
In 2010, the company launched mass recalls of certain children's over-the-counter-medicines, including Infants' Tylenol and Children's Motrin, made at its Fort Washington, Pennsylvania plant.
It was the latest in a series of recalls at the time. There were far-reaching multiple recalls from 2008 to 2010 involving hundreds of millions of bottles and packages of consumer brands such as Tylenol, Motrin, Rolaids, Benadryl and other products due to faulty manufacturing. The recalls kept widely used products such as Children's Tylenol off pharmacy shelves and seriously tarnished J&J's once-sterling reputation.
In addition to metal particles getting into liquid medicines, there were moldy odors and labeling problems. For example, the label for Sudafed allergy tablets incorrectly repeated the word "not" to say "do not not divide, crush, chew or dissolve the tablet."
In the case involving metal particles, the troubles began in May 2009 when a consumer complained after noticing "black specks" in the bottom of a bottle of Infants' Tylenol. The specks were found to be nickel and chromium particles.
In 2010, Johnson & Johnson's U.S. consumer product sales fell by more than 19 percent, a decrease of $900 million. The rash of consumer medicine recalls in 2009 and 2010 were largely responsible for the first back-to-back years of company sales declines since World War Two.
Carol Goodrich, a spokeswoman for McNeil Consumer Healthcare, said the plea agreement "closes a chapter" and that the company has "been implementing enhanced quality and oversight standards across its entire business."
As part of the agreement, McNeil also agreed to further safety measures before reopening its Fort Washington facility.
(Additional reporting by Bill Berkrot and Ransdell Pierson; Editing by Jonathan Oatis)
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Maker of kids' Tylenol pleads guilty over metal particles
Mar 10, 2015 | AP (Yahoo News)
By Michael Rubinkam and MaryClaire Dale
PHILADELPHIA (AP) — A subsidiary of Johnson & Johnson pleaded guilty Tuesday to a federal criminal charge that it sold over-the-counter infant's and children's liquid medicine containing metal particles.
McNeil Consumer Healthcare, of Fort Washington, Pennsylvania, acknowledged failing to take corrective action after discovering the adulterated bottles of Infants' and Children's Tylenol and Children's Motrin. The company agreed to pay $25 million to resolve the case.
Metal particles, including nickel, iron and chromium, were introduced during the manufacturing process at McNeil's plant in Fort Washington. Prosecutors said McNeil knew about the problem for nearly a year but failed to take immediate steps to fix it.
The company and prosecutors said in court Tuesday that no one was injured.
"McNeil's failure to comply with current good manufacturing practices is seriously troubling," Acting Assistant Attorney General Mizer said in a statement after the judge accepted McNeil's plea.
"The Department of Justice will continue to be aggressive in pursuing and punishing companies such as McNeil that disregard a process designed to assure quality medicines, especially OTC drugs for infants and children," he said.
McNeil is a unit of Johnson & Johnson. The New Brunswick, New Jersey, health care giant has struggled with scores of product recalls since 2009.
In this case, McNeil first learned of the particle problem in May 2009, when a consumer complained about black specks inside a bottle of Infants' Tylenol, according to court documents. McNeil subsequently found metal particles during production but continued making the liquid medicines for several more months.
"There were investigative steps taken, but not all of the steps required under all of our internal operating procedures," company attorney Michael Schwartz told The Associated Press on Tuesday.
McNeill eventually traced the problem to the machinery at its plant in Fort Washington and issued a recall. The Food and Drug Administration said the potential for serious medical problems was remote but advised consumers to stop using the medicine.
The suburban Philadelphia plant — which was linked to several recalls of Tylenol and other nonprescription drugs for children and adults — was shuttered in April 2010 and rebuilt from the ground up, but it has yet to reopen.
The company is operating under an agreement with the FDA requiring increased inspections and oversight at its factories.
McNeil said Tuesday it has significantly improved its procedures.
"McNeil has been implementing enhanced quality and oversight standards across its entire business to ensure we are best able to meet our commitment to consumers, patients and doctors who rely on our products," company spokeswoman Carol Goodrich said.
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AP Business Writer Linda A. Johnson in Trenton, N.J., contributed to this report.
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