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McNeil Announcement - 3/10/15
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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. -
Johnson & Johnson Subsidiary to Pay $25 Million In Penalties
Mar 11, 2015 | Diabetes Insider
By Paola Celedonio
McNeil Consumer Healthcare is a subsidiary of home and health care product conglomerate Johnson & Johnson. You might know the Fort Washington Pennsylvania company better as the manufacturers of Children’s Tylenol and Children’s Motrin medicines. -
J&J's McNeil-PPC pays $25m over manufacturing adulterated infants’, children’s OTC medicines
Mar 11, 2015 | Pharmaceutical Business Review
Johnson & Johnson's McNeil-PPC has pleaded guilty to a federal criminal charge that it sold over-the-counter (OTC) infant's and children's liquid medicine containing metal particles. -
Tylenol Manufacturer Must Pay $25M for Selling Metal-Contaminated Drugs
| All Media NY
By Samantha Wilson
Johnson & Johnson subsidy McNeil Consumer Healthcare pleaded guilty Tuesday to selling liquid medicine contaminated with metal, agreeing to pay $25 million in the case and to further implement safety measures at the plant where the contamination occurred. They pleaded guilty to one federal criminal charge in the suit. -
Is $25 Million Enough For Contaminating Tylenol?
Mar 11, 2015 | 2 Paragraphs - Blog
McNeil Consumer Healthcare, a Johnson & Johnson subsidiary, agreed to pay $25 million and plead guilty to a federal criminal charge for selling medicines contaminated with metal.
McNeil Announcement - Traditional Media Coverage 3/10/15
Full Text of Stories Below
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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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Johnson & Johnson Subsidiary to Pay $25 Million In Penalties
Mar 11, 2015 | Diabetes Insider
By Paola Celedonio
McNeil Consumer Healthcare is a subsidiary of home and health care product conglomerate Johnson & Johnson. You might know the Fort Washington Pennsylvania company better as the manufacturers of Children’s Tylenol and Children’s Motrin medicines.
Well, unfortunately, McNeil has agreed to plead guilty to a federal criminal charge which purports that they had sold children’s over-the-counter medications which had particles of metal in the liquid. In the case, McNeil has agreed to pay $25 million in penalties.
“The proposed criminal resolution is sufficient to punish McNeil for its past failures and to deter McNeil from violating [federal law in the future],” explained the prosecutors in a memo provided for the judge overseeing the case.
After the judge accepted the plea, Acting Assistant Attorney General Mizer commented, “McNeil’s failure to comply with current good manufacturing practices is seriously troubling. 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.”
Accordingly, company attorney Michael Schwartz told the Associated Press, on Tuesday, that “There were investigative steps taken, but not all of the steps required under all of our internal operating procedures.”
The case details that McNeil first learned of this “particle” problem in May of 2009. A consumer actually complained that they found black specks in a bottle of infant’s Tylenol. A quick investigation determined that the black specks were metal particles left behind during the production process. However, even after knowing about the problem, McNeil continued to make more of the liquid product.
Additionally, company spokeswoman Carol Goodrich comments, “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.”
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J&J's McNeil-PPC pays $25m over manufacturing adulterated infants’, children’s OTC medicines
Mar 11, 2015 | Pharmaceutical Business Review
Johnson & Johnson's McNeil-PPC has pleaded guilty to a federal criminal charge that it sold over-the-counter (OTC) infant's and children's liquid medicine containing metal particles.
As per the information, the OTC liquid drugs manufactured at the company's Fort Washington facility, including Infants' and Children's Tylenol and Infants' and Children's Motrin, were adulterated. They were not manufactured, processed, packed or held in conformance with current Good Manufacturing Practices (cGMP), in violation of the federal Food, Drug and Cosmetic Act (FDCA).
These OTC liquid drugs manufactured at the Fort Washington facility were bottled on four lines of machinery dedicated to liquid formulations.
Justice Department Civil Division acting assistant attorney general Benjamin Mizer said: "McNeil's failure to comply with current good manufacturing practices is seriously troubling.
"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."
The company first learned of the particle problem in May 2009, when a consumer complained about black specks inside a bottle of Infants' Tylenol.
The foreign material including nickel/chromium-rich inclusions, which were not intended ingredients in this OTC liquid drug, but upon receiving the consumer complaint, the company did not start or complete a Corrective Action Preventive Action (CAPA) plan.
During a 2010 inspection at the Fort Washington facility, the US Food and Drug Administration (FDA) asked the company for a list with all non-conformances for particles and the associated OTC drug batches that had occurred since an FDA inspection in 2009.
The Fort Washington plant, which was linked to several recalls of Tylenol and other OTC drugs for children and adults, was shut down in April 2010 and completely rebuilt, but is yet to re-open.
In order to resolve this issue, the company has agreed to pay a criminal fine of $20m and forfeit $5m.
The US District Court for the Eastern District of Pennsylvania accepted the company's guilty plea.
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Tylenol Manufacturer Must Pay $25M for Selling Metal-Contaminated Drugs
| All Media NY
By Samantha Wilson
Johnson & Johnson subsidy McNeil Consumer Healthcare pleaded guilty Tuesday to selling liquid medicine contaminated with metal, agreeing to pay $25 million in the case and to further implement safety measures at the plant where the contamination occurred. They pleaded guilty to one federal criminal charge in the suit.
In 2010, the company launched a number of recalls on children’s over-the-counter medicines made at its Fort Washington, Pennsylvania plant. These included Infant’s Tylenol and Children’s Motrin. But it was just one in a string of recalls happening at the time. From 2008 to 2010, hundreds of millions of bottles of medicinal brands like Tylenol, Motrin, Rolaids, Benadryl were recalled due to faulty manufacturing. The recall controversy kept widely-used products out of stores and seriously damaged Johnson & Johnson’s reputation.
The case involving metal particles began in May 2009, when a customer noticed “black specks” at the bottom of her bottle of Infant’s Tylenol; the specks were nickel and chromium particles. In addition to the metal, the Fort Washington plant also was found to have moldy odors and problems with labeling medicines correctly.
According to Carol Goodrich, a spokeswoman for McNeil Consumer Healthcare, the plea agreement “closes a chapter”, and that McNeil has "been implementing enhanced quality and oversight standards across its entire business.”
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Is $25 Million Enough For Contaminating Tylenol?
Mar 11, 2015 | 2 Paragraphs - Blog
McNeil Consumer Healthcare, a Johnson & Johnson subsidiary, agreed to pay $25 million and plead guilty to a federal criminal charge for selling medicines contaminated with metal. The products included Infants' Tylenol and Children's Motrin. The company recalled hundreds of millions of units of its various consumer brands from 2008-2010 for errors in packaging, labeling and the presence of metal particles.
Johnson & Johnson reported a decrease in sales of $900 million in 2010, due to an inability to keep its products on store shelves and a deficit in consumer trust. But even that $900 million reduced J&J's total sales by less than 20 percent. Is the $25 million a meaningful penalty? The Pennsylvania plant that produced the contaminated J&J products remains open. It will be subject to more safety measures as part of the new settlement, which begs the question: safety measures that haven't already been implemented?
McNeil Announcement - Traditional Media Coverage 3/10/15
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