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McNeil Announcement - Media Coverage Report 3/11/15 - 1PM
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Tylenol Maker Pleads Guilty to Selling Children's Medicine Contaminated with Metal, Will Pay $25 Million
Mar 11, 2015 | Latin Post
By Robert C. Weich III
A Johnson & Johnson subsidiary plead guilty to selling liquid medicine contaminated with metal on Tuesday. -
McNeil pleads guilty in Federal District Court
Mar 11, 2015 | New Hampshire Voice
By Emma Tiller
On Tuesday, Johnson & Johnson subsidiary McNeil-PPC Inc pleaded guilty in Federal District Court in Philadelphia to one count of information charging the company for selling liquid medicine contaminated with metal. -
J & J's McNeil unit to pay $25M to settle federal probe
Mar 11, 2015 | Seeking Alpha
By Douglas House
Johnson & Johnson's (NYSE:JNJ) McNeil consumer products business agrees to pay $25M to settle a U.S. government probe into a Pennsylvania-based facility that recalled Tylenol and other OTC medicines several years ago due to quality lapses. -
Johnson & Johnson (NYSE:JNJ) To Pay $25 Million In Fine For Faulty Manufacturing
Mar 11, 2015 | Bidness Etc.
By Hannah Ishmael
Johnson and Johnson (NYSE: JNJ) subsidiary, McNeil Consumer Healthcare admitted to negligence as it agreed to pay $25 million in fine to resolve a case in which it was found to have sold liquid pain relief medicine contaminated with metal, said the US Department of Justice on Tuesday. -
Tylenol maker pleads guilty to selling contaminated children’s medicine
| Examiner
By Gillian Burdett
Johnson & Johnson subsidiary McNeil-PPC Inc. pleaded guilty to criminal charges it sold adulterated Infant’s and Children’s liquid medicines, the U.S. Department of Justice (DOJ) reported yesterday. -
McNeil Pleads Guilty In Criminal Court For Knowingly Selling Tainted Infant Tylenol And Motrin
Mar 11, 2015 | Inquisitr
McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, is under public scrutiny after pleading guilty in criminal court Tuesday of selling tainted infant Tylenol and Motrin. -
Tylenol maker admits to selling medicine contaminated with metal
Mar 11, 2015 | The Week Magazine
By Meghan DeMaria
McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, reached a $25 million settlement with the Department of Justice on Tuesday. -
Maker of Children’s Tylenol, Motrin to Plead Guilty to Selling Contaminated Medications
Mar 11, 2015 | Health Magazine - News & Views Blog
The maker of liquid Tylenol and Motrin for children and infants has agreed to plead guilty Tuesday to selling the over-the-counter medications even though the bottles were contaminated with metal particles. -
Tylenol Maker Guilty of Selling Contaminated Children's Medicine
Mar 11, 2015 | The Stir - Cafe Mom Blog
By Judy Dutton
This is all kinds of crazy: A Johnson & Johnson subsidiary has admitted to selling Infant Tylenol contaminated with metal.
McNeil Announcement - Media Coverage Report 3/11/15
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Mar 11, 2015 | Latin Post
By Robert C. Weich III
A Johnson & Johnson subsidiary plead guilty to selling liquid medicine contaminated with metal on Tuesday.
The company has agreed to pay $25 million to settle the case, the U.S. Department of Justice saidaccording to Reuters.
McNeil Consumer Healthcare was the subsidiary that pleaded guilty to one federal criminal charge in the case.
Prosecutors say that McNeil knew about the problem with metal in the children's drugs for more than a year but failed to act quickly to fix the problem. The company acknowledges failing to take quick action, according to the Associated Press.
Back in 2010, the company recalled massive amounts of children's over-the-counter medicines such as Infants' Tylenol and Children's Motrin, both made at the company's Fort Washington, Pennsylvania plant.
Those were not the first recalls. The company began multiple recalls from 2008 to 2010. Hundreds of millions of bottles and packages of brands like Tylenol, Motrin, Rolaids, Benadryl and other products were recalled because of faulty manufacturing. These recalls kept popular medicines like Children's Tylenol off store shelves and hurt Johnson & Johnson's reputation.
Metal particles got into liquid medicines and moldy odors and labeling problems also caused recalls. On the label for Sudafed, the instructions repeated "not" to read: "do not not divide, crush, chew or dissolve the tablet."
The metal particles problem began in 2009 when a consumer reported seeing "black specks" at the bottom of a bottle of Infants' Tylenol. Those specks turned out to be nickel and chromium particles.
By 2010, consumer product sales for Johnson & Johnson in the U.S. had fallen by more than 19 percent, a decrease of more than $900 million. All of the recalls were a big reason why the company reported back-to-back sales declines in 2009 and 2010 for the first time since World War II.
A McNeil Consumer Healthcare spokeswoman said that the plea agreement "closes a chapter" and the company has been installing better quality and oversight standards throughout the entire business.
More safety measures will be installed before McNeil reopens its Fort Washington plant.
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McNeil pleads guilty in Federal District Court
Mar 11, 2015 | New Hampshire Voice
By Emma Tiller
On Tuesday, Johnson & Johnson subsidiary McNeil-PPC Inc pleaded guilty in Federal District Court in Philadelphia to one count of information charging the company for selling liquid medicine contaminated with metal. According to the United States Department of Justice, the company has agreed to pay about $25 million to resolve the case. Out of $25 million, $20 million will be paid as criminal fine, while $5 million as forfeit.
About four years ago, the company had launched recalls of some medicines, including Infants' Tylenol and Children's Motrin. The medicines were made at the company's Fort Washington plant.
As per the criminal charge, the infants' liquid medicines were adulterated because they were not made or packed conformance with current Good Manufacturing Practices. It was violation of the Food, Drug and Cosmetic Act of federal government. Apart from metal particles, there were also moldy odors and labeling problems. The Sudafed allergy tablets of the company had incorrectly repeated the word 'not' in place of 'do not divide, crush, chew or dissolve the tablet'.
In the case involving metal particles, the troubles for the company had started in 2009 when a customer complained after noticing 'black specks' in a bottle of Infants' Tylenol. According to the customer, the specks were nickel and chromium particles. In 2010, the company's product sales fell by about 19%.
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 per the reports, McNeil's guilty plea has been accepted by the District Court for the Eastern District of Pennsylvania. The company has agreed to further safety measures before opening its Fort Washington facility once again, as per the reports.
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J & J's McNeil unit to pay $25M to settle federal probe
Mar 11, 2015 | Seeking Alpha
By Douglas House
Johnson & Johnson's (NYSE:JNJ) McNeil consumer products business agrees to pay $25M to settle a U.S. government probe into a Pennsylvania-based facility that recalled Tylenol and other OTC medicines several years ago due to quality lapses. Under the terms of the settlement agreement, McNeil pleads guilty to a misdemeanor violation and accepts responsibility for the inadequate filing of required documents during the manufacturing process. It will pay a $20M criminal fine and forfeit $5M.The Fort Washington, PA plant was shut down in 2010 and has yet to reopen. Problems included excessive concentrations of active ingredients and musty-smelling products. The recalls included Zyrtec and Benadryl, in addition to Tylenol.McNeil's remaining U.S. facilities continue to operate, although under a 2011 permanent injunction. -
Johnson & Johnson (NYSE:JNJ) To Pay $25 Million In Fine For Faulty Manufacturing
Mar 11, 2015 | Bidness Etc.
By Hannah Ishmael
Johnson and Johnson (NYSE: JNJ) subsidiary, McNeil Consumer Healthcare admitted to negligence as it agreed to pay $25 million in fine to resolve a case in which it was found to have sold liquid pain relief medicine contaminated with metal, said the US Department of Justice on Tuesday.
McNeil Consumer Healthcare began recalling massive amounts of the over-the-counter pain relief medicine including Infant Tylenol as well as Children's Motrin made in its Fort Washington, PA. plant. This is the latest in a series of recalls where Johnson & Johnson has been held responsible for multiple manufacturing faults. The company has issued a number of recalls since 2008 through 2010. These recalls kept Infant Tylenol off pharmacy shelves, severely tarnishing J&J's reputation. A McNeil plant was closed down in 2010 and has yet to re-open.
Metal particles weren’t the only problem for the New Jersey-based giant. There were moldy odors as well as labeling problems. The metal contamination began in May 2009 when consumers reported "back specks" or blackish residue at the bottom of Infant Tylenol. These flecks were later found to be particles of nickel and chromium.
Johnson & Johnson reported in 2010 that its consumer product sales in the US fell by over 19%, marking a sales decline of $900 million. The sales declines were largely attributable to the recalls in 2009 an 2010. These resulted in two consecutive fiscal year sales declines for the first time since World War II.
Carol Goodrich, a spokeswoman for McNeil Consumer Healthcare said that the "plea agreement closes a chapter" in the company's history and that the "company has been implementing enhanced quality and oversight standards across its entire business" to avoid a repeat of the events.
The Justice Department says McNeil is working to bring its Fort Washington facility back into compliance once it gets clearance from the US Food and Drug Administration. McNeil's facilities, apart from the one based in Pennsylvania, are operating under a 2011 permanent injunction.
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Tylenol maker pleads guilty to selling contaminated children’s medicine
| Examiner
By Gillian Burdett
Johnson & Johnson subsidiary McNeil-PPC Inc. pleaded guilty to criminal charges it sold adulterated Infant’s and Children’s liquid medicines, the U.S. Department of Justice (DOJ) reported yesterday. The charges stem from a May 2009 consumer complaint that a bottle of Infant’s Tylenol contained black specks. The DOJ claims McNeil failed to take corrective action. Further inspections reveled that 30 batches of liquid drugs, including Infants’ Tylenol, Children’s Tylenol, and Children’s Motrin, were contaminated. The company agreed to pay $25 million to resolve the case.
The foreign material found in the over-the-counter medicines were identified as nickel/chromium metal particles. All the adulterated products were bottled at the company’s Fort Washington, Pennsylvania facility. April 30, 2010, McNeil announced a voluntary recall of the affected products. The company claimed the recall was precautionary and not the result of adverse medical events. In all, 44 lots of children’s and infant’s liquid medicines were recalled for possibly containing metal flakes.
This is not the first time safety issues have been raised with Tylenol products. In 2009 and 2010, McNeil, in cooperation with the U.S. Food and Drug Administration, issued several recalls of medicines that consumers complained had an “unusual moldy, musty, or mildew-like odor.” McNeil’s investigation determined the odor came from wood pallets used to store and transport the products. Consumer complaints of nausea, vomiting, diarrhea and stomach pains were associated with these medicines.
McNeil is subject to a permanent injunction entered by the U.S. District Court in 2011, which requires the company to take remedial measures before reopening its Fort Washington, Pennsylvania manufacturing facility. “When companies fail to exercise the vigilance that the law demands,” says First Assistant U.S. Attorney Louis D. Lappen of Pennsylvania’s Eastern District, “ they will be held accountable. Drug companies should be aware that failing to adhere to good manufacturing practices subjects them to penalties and prosecution.” The federal Food, Drug and Cosmetics Act requires products are manufactured, processed and packed in conformance with current Good Manufacturing Practices.
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McNeil Pleads Guilty In Criminal Court For Knowingly Selling Tainted Infant Tylenol And Motrin
Mar 11, 2015 | Inquisitr
McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, is under public scrutiny after pleading guilty in criminal court Tuesday of selling tainted infant Tylenol and Motrin. Reports alleged that McNeil Consumer Healthcare continued to sell product after the company was made aware that the infant Tylenol and Motrin was tainted with metal particles including chromium, iron, and nickle. In addition, an earlier report stated that the Tylenol and Motrin might have been in inconsistent quantities in the liquid drops, according to an RT report.
The metals were reportedly introduced during the manufacturing process at McNeil Consumer Healthcare’s plant in Fort Washington, Pennsylvania. McNeil was first made aware of possible contamination in May 2009, after a consumer complained that there was black specks inside a bottle of purchased Infants’ Tylenol, court documents assert. After checking the problem, McNeil quality control did find metal particles during production. After finding metal particles in the medication meant for infants and children, McNeil continued to manufacture and sell the liquid medication that are often used for teething, fever, aches and pains and after vaccination on infants and children.
McNeil began a voluntary recall in April 2010. On May 1, 2010, a notice was made to the public by the FDA of what they called a “voluntary recall.” The recall information didn’t specify the exact findings, but instead stated that the drugs didn’t meet quality standards and that the recall was introduced as a precaution. According to that recall notice, the products made for infants and children included some Tylenol, Motrin, Zyrtec, and Benadryl products.
“McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. As a precautionary measure, parents and caregivers should not administer these products to their children. Some of the products included in the recall may contain a higher concentration of active ingredient than specified; others contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. While the potential for serious medical events is remote, FDA advises consumers who have purchased these recalled products to discontinue use.”
At that time, the FDA Commissioner Dr. Margaret A. Hamburg stated that the potential for serious health problems as a result of the tainted medications were “remote” and that the recall was issued, because “Americans deserve medications that are safe, effective and of the highest quality.”
McNeil acknowledged Tuesday by pleading guilty in accordance with a plea deal to the federal criminal charge that it sold the over-the-counter infant’s and children’s without taking corrective action after the discovery that the Tylenol and Motrin had been tainted. The plea deal resulted in the company agreeing to pay 25 million dollars and pleading guilty in order to resolve the case.
“McNeil’s failure to comply with current good manufacturing practices is seriously troubling,” the acting Assistant Attorney General Mizer said in a statement. “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.”
Though the FDA said that the possibility of health concerns due to the contamination of the Tylenol and Motrin that was produced from the Fort Washington McNeil plant, the public is now questioning a previous death that had been alleged to have been due to taking only one dose of infant’s Tylenol. In 2012, Shawn Arndt sued the company claiming that Arndt’s son Joshua died at 4-years-old after taking Tylenol. Mr. Arndt alleged that after taking the Tylenol, his son began bleeding from the nose and later died. According to court documents, the bottle of Tylenol that was used in the dose given to Joshua was included in the recall. Johnson & Johnson asked for the case to be dismissed, because Mr. Arndt’s suit wasn’t filed within the two-year statute of limitations period. The US District Court for Eastern Pennsylvania dismissed Arndt’s suit in part against the company (which had since closed that McNeil plant) in December 2014.
According to FDA documentation, when the recall was initiated, McNeil also made “solid oral dosage forms at that facility,” and that McNeil shut down the production of those adult versions as well. However, that report stated that at that time, there was no indication that a recall on the adult versions of the drugs was warranted. Additional detailed information into McNeil‘s inspections is available for public viewing on the FDA’s website. The FDA investigation, according to RT, traced the Tylenol and Motrin contamination to machinery in the McNeil plant which came from violations in manufacturing and also from “airborne contamination from a chemical used for wood pallets.
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Tylenol maker admits to selling medicine contaminated with metal
Mar 11, 2015 | The Week Magazine
By Meghan DeMaria
McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, reached a $25 million settlement with the Department of Justice on Tuesday. The Tylenol makerpleaded guilty to selling liquid medicines that were contaminated with metal.
In 2010, the company recalled medicines including Infants' Tylenol and Childrens' Motrin. Reuters reports that the issues began in 2009, when a customer reported "black specks" in Infants' Tylenol, and the specks turned out to be nickel and chromium. The liquid medicines that were contaminated with metal often had "moldy odors," too, Reuters notes.
The agreement also included furthering safety measures at McNeil's Fort Washington facility before it reopens.
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Maker of Children’s Tylenol, Motrin to Plead Guilty to Selling Contaminated Medications
Mar 11, 2015 | Health Magazine - News & Views Blog
The maker of liquid Tylenol and Motrin for children and infants has agreed to plead guilty Tuesday to selling the over-the-counter medications even though the bottles were contaminated with metal particles.
McNeil Consumer Healthcare will pay $25 million as part of its plea agreement, the Associated Press reported. The Fort Washington, Pa.-based company, a unit of Johnson & Johnson, was facing a federal criminal charge for knowing for nearly a year that metal particles, including nickel, iron and chromium, were getting inside the bottles of medicine during the manufacturing process.
Although no immediate steps were taken to fix the problem, the Fort Washington plant where the contaminations occurred was shut down in 2010 and a new, yet-to-open plant has been built in its stead, the AP reported.
McNeil was first alerted to the problem in 2009 following a customer complaint, but the company kept selling the medications for several months before issuing a recall, according to the AP. At the time, the U.S. Food and Drug Administration said the chances for serious medical problems were unlikely, but it advised consumers to stop taking the medications, the wire service reported.
The health care company is currently in an agreement with the FDA that includes increased inspections and oversights at it manufacturing plants, according to the AP.
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Tylenol Maker Guilty of Selling Contaminated Children's Medicine
Mar 11, 2015 | The Stir - Cafe Mom Blog
By Judy Dutton
This is all kinds of crazy: A Johnson & Johnson subsidiary has admitted to sellingInfant Tylenol contaminated with metal. The case has resulted in wide recalls, while the manufacturer, McNeil Consumer Healthcare, has coughed up $25 million and promised to clean up their act. Still, many parents may be wondering: are these baby meds safe? Can this company be trusted?
It all began in 2009, when an consumer complained of black specks in a bottle of Infant's Tylenol. Those particles were found to be nickel, iron and chromium, and although no reports have surfaced of injuries, that sure doesn't sound good!
Nonetheless, the manufacturer, Johnson & Johnson subsidiary McNeil Consumer Healthcare, knowingly kept these contaminated bottles on the market for a year before they issued a massive recall of millions of bottles of infant and children's liquid meds, and other products.
Meanwhile, an investigation by the FDA revealed that the manufacturing plant was an unhygienic mess, and has since been closed.
Leery of buying another bottle of Infant or Children's Tylenol? We totally get it! It's sad to see that the very thing we hope will help our sick kids feel better could be undermining their health. I'm also horrified how long it took for justice to be served: six years. Seriously?
But I guess the semi-good news is that McNeil is currently working with the FDA to raise the bar on their manufacturing standards with increased inspections and oversight. So, that's certainly a step in the right direction, and should soothe parents' concerns, at least somewhat.
How do you feel about buying infant or children's Tylenol now?
McNeil Announcement - Media Coverage Report 3/11/15
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