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Local Company Admits Selling Tainted Children's Medications
Mar 11, 2015 | Patch
By Kara Seymour
A Montgomery County healthcare company will pay $25 million after pleading guilty to selling children’s medications tainted with nickel and chromium, the U.S. Department of Justice announced Tuesday. -
Fort Washington-based McNeil to pay $25 million in plea agreement over adulterated drugs
Mar 11, 2015 | Montgomery News - Amber Gazette
By Eric Fitzsimmons
McNeil Consumer Healthcare will have to pay $25 million as part of the plea agreement to charges that it failed to adequately respond to multiple reports of contaminants in over-the-counter children’s medicines produced in its plant in the Fort Washington section of Whitemarsh Township in 2009 and 2010, according to a release Tuesday. -
Manufacturing mess at J&J consumer plant results in guilty plea, $20M fine
Mar 11, 2015 | FiercePharma Manufacturing
By Eric Palmer
The McNeil Consumer Healthcare plant in Pennsylvania where a laissez-faire attitude about quality led Johnson & Johnson ($JNJ) into a regulatory quagmire has now led the drugmaker to plead guilty to a federal misdemeanor charge and fork over $25 million. -
McNeil Settles Tainted Tylenol Charges for $25M
Mar 11, 2015 | Courthouse News Service
By Andrew Thompson
After pleading guilty to stalling the recall of tainted children's medicines, Johnson & Johnson subsidiary McNeil-PPC owes $25 million. -
Maker Of Children's Tylenol Contaminated With Metal Particles Pleads Guilty
Mar 11, 2015 | Yahoo! Health
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. -
Johnson & Johnson subsidiary to pay $25M fine over children's Tylenol recall
Mar 11, 2015 | UPI
By Danielle Haynes
A Johnson & Johnson subsidiary has agreed to pay a $25 million criminal fine associated with a recall in 2009 of over-the-counter liquid children's medicines that had particles in them. -
Company behind Infant's Tylenol and Motrin to pay $25 million
Mar 11, 2015 | She Knows - Blog
By Monica Beyer
A company knew that they were producing contaminated children's medication, yet continued to make and sell it for another year — which is now costing them $25 million. -
Tylenol Maker Admits To Selling Drugs Contaminated With Metals
Mar 11, 2015 | Tech Times
By Jim Algar
A subsidiary of Johnson & Johnson has pleaded guilty to selling liquid medications that had been contaminated with metal during the manufacturing process, the U.S. Department of Justice says.
McNeil Announcement - Media Coverage Report 3/11/15 - 7 PM
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Local Company Admits Selling Tainted Children's Medications
Mar 11, 2015 | Patch
By Kara Seymour
A Montgomery County healthcare company will pay $25 million after pleading guilty to selling children’s medications tainted with nickel and chromium, the U.S. Department of Justice announced Tuesday.
According to authorities, McNeil produced the tainted Infants’ Tylenol, Children’s Tylenol and Children’s Motrin at its facility in Fort Washington and failed to follow proper protocols after receiving consumer complaints.
In 2009, a consumer alerted the company that there were “black specks” in the liquid at the bottom of the bottle of Infants Tylenol, according to court documents. It was later determined to be nickel and chromium in the medication, which was not intended as ingredients.
After receiving the complaint, McNeil, a subsidiary of Johnson & Johnson, did not initiate or complete a Corrective Action Preventive Action plan in conformance with current Good Manufacturing Practices, the Department of Justice said in a statement.
A subsequent Food and Drug Administration investigation revealed metal particles were found in as many as 30 batches of children’s medications manufactured at the Fort Washington facility, according to information from the Department of Justice. The company did not follow protocols in those instances, either, the Department of Justice said.
In April 2010, McNeil announced a recall of certain unexpired infants’ and children’s drugs manufactured at the Fort Washington facility.
McNeil was charged with delivery for introduction into interstate commerce drugs that were deemed adulterated. As a result of the guilty plea, the company must pay a criminal fine of $20 million and forfeit $5 million.
“The law requires that drugs be produced under the most rigorous of quality standards. When companies fail to exercise the vigilance that the law demands, they will held be accountable” said First Assistant U.S. Attorney Louis D. Lappen. “Drug companies should be aware that failing to adhere to good manufacturing practices subjects them to penalties and prosecution.”
McNeil remains under a 2011 permanent injunction requiring it to make remedial measures before reopening its Fort Washington manufacturing facility.
“Drug quality – and especially with the medicines we give our children – is of paramount concern to the FDA. The FDA expects manufacturers to have systems in place that will quickly discover and correct problems with medical products before they enter the U.S. marketplace,” said Margaret A. Hamburg, M.D., Commissioner, U.S. Food and Drug Administration.
The case was investigated by the Food and Drug Administration Office of Criminal Investigations.
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Fort Washington-based McNeil to pay $25 million in plea agreement over adulterated drugs
Mar 11, 2015 | Montgomery News - Amber Gazette
By Eric Fitzsimmons
McNeil Consumer Healthcare will have to pay $25 million as part of the plea agreement to charges that it failed to adequately respond to multiple reports of contaminants in over-the-counter children’s medicines produced in its plant in the Fort Washington section of Whitemarsh Township in 2009 and 2010, according to a release Tuesday.
McNeil, which has offices based in the Fort Washington Office Park in Upper Dublin, said it had entered into an agreement with the U.S. Attorney’s Office and the Department of Justice under which the company would plead guilty to a misdemeanor violation of the Federal Food, Drug and Cosmetic Act and pay a $25 million settlement, according to a statement.
According to the sentencing memo, McNeil, a subsidiary of Johnson & Johnson, was charged with a misdemeanor stemming from its failure to initiate a Corrective Action Prevention Action plan in response to reports, beginning in May 2009, of metallic particles in its OTC liquid drugs for children and infants that were not among the intended ingredients.
The settlement stated that a customer complained in May 2009 of “black specks,” which McNeil found to have metallic elements. It also said the company found similar particles in January, March and April 2010, but continued to produce liquid children’s and infants’ medicines at the Fort Washington plant until April 13, 2010.
The misdemeanor charge, according to the memo, was “one count of delivery for introduction into interstate commerce drugs that were deemed adulterated because they were not manufactured in conformity with cGMP.”
The memo stated that a drug is deemed adulterated without demonstration of actual defects if the methods used in the manufacture or distribution are not in conformity with current practices.
Principal Deputy Commissioner Joshua M. Sharfstein, M.D., of the FDA, said to Congress in May 2010, “[A]lthough the public health risk from these quality problems is low, these problems should never have occurred, and the cGMP failures at the facility that caused them were unacceptable,” according to the memo.
After an inspection in April 2010 by the FDA McNeil did suspend production at the Fort Washington facility and announced a voluntary recall of all pediatric liquid OTC drugs produced there including liquid children’s and infants’ Benadryl, Motrin, Tylenol and Zyrtec.
There were more than 136 million bottles of pediatric drugs in that recall, which made it the largest recall of children’s medication in history. This was followed by several more recalls by the company over the subsequent year.
The Fort Washington facility was the only one producing many of the drugs, which were unavailable for a time as production was moved to other Johnson & Johnson plants.
The company entered a consent decree of permanent injunction with the FDA in 2011, which remains to ensure compliance with current Good Manufacturing Processes going forward.
The memo stated the Fort Washington manufacturing plant was to remain closed as part of that consent decree until it could be brought to current standards of manufacturing but has not, to this point, reopened.
McNeil’s statement said it is also working with the FDA on its Lancaster and Las Piedras, Puerto Rico, facilities. It said that a third party cGMP expert has determined all three sites to be up to current regulations and has submitted written certification on that point to the FDA.
In light of the ongoing consent decree, the agreement stated that McNeil will not be placed under probation.
McNeil, in the statement, said it “accepts responsibility for the inadequate filing of required documents during the manufacturing process.”
In the statement, Carol Goodrich, a spokesperson for McNeil, said, “This plea agreement fully and finally resolves the federal government’s investigation and closes a chapter that led the company to review and significantly improve its procedures.”
She added, “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.”
In a statement from the DOJ, Acting Assistant Attorney General Benjamin Mizer said, “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. -
Manufacturing mess at J&J consumer plant results in guilty plea, $20M fine
Mar 11, 2015 | FiercePharma Manufacturing
By Eric Palmer
The McNeil Consumer Healthcare plant in Pennsylvania where a laissez-faire attitude about quality led Johnson & Johnson ($JNJ) into a regulatory quagmire has now led the drugmaker to plead guilty to a federal misdemeanor charge and fork over $25 million.
J&J will pay a $20 million fine and forfeit $5 million after it agreed to plea to a charge that it delivered for introduction into interstate commerce drugs that were deemed adulterated.
The plea agreement announced by Justice Department and FDA officials Tuesday stemmed from a complaint that McNeil's plant in Fort Washington, PA, received in 2009, that there were "black specks in the liquid on the bottom of the bottle" of Infants' Tylenol. But instead of initiating a Corrective and Preventive Action (CAPA) plan, officials there did essentially nothing. In fact, the FDA would determine that the plant had received about 30 similar complaints in 2009 and 2010 but failed to take required actions, at least until FDA inspectors showed up in 2010.
An investigation found that those specks were particles of nickel and chromium coming off of machinery. Authorities said no consumers were harmed as a result, but J&J voluntarily recalled and destroyed tens of millions of consumer products it had shipped worldwide. The plant issues resulted in a court-ordered permanent injunction.
"The law requires that drugs be produced under the most rigorous of quality standards," First Assistant U.S. Attorney Louis Lappen said in a statement. "When companies fail to exercise the vigilance that the law demands, they will held be accountable. Drug companies should be aware that failing to adhere to good manufacturing practices subjects them to penalties and prosecution."
On Tuesday, J&J accepted "responsibility for the inadequate filing of required documents during the manufacturing process" and said it will pay a settlement of $25 million. But it also said that the voluntary recalls "were not undertaken because of health or safety risks to consumers."
McNeil spokesperson Carol Goodrich said in an emailed statement: "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. 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."
Having to strip retailers' shelves bare of its most popular OTC meds reportedly cost the company at least $1.6 billion in lost sales and expenses and cost some of its top execs their jobs. The company closed the plant and spent $100 million to completely overhaul the facility and its production lines, although the plant has yet to reopen. Goodrich told FiercePharmaManufacturing that McNeil has "completed the steps required for third party certification" and that its expert has submitted written certification to the FDA. The company is now awaiting an FDA reinspection so that the plant can return to production.
In 2012, CEO Alex Gorsky hired Sandra Peterson from Bayer to deal with the issues created by the deeply troubled plant. Peterson has been able to arrange for enough production to meet retailer's demand for J&J OTC products, resulting in a surge in sales last year.
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McNeil Settles Tainted Tylenol Charges for $25M
Mar 11, 2015 | Courthouse News Service
By Andrew Thompson
After pleading guilty to stalling the recall of tainted children's medicines, Johnson & Johnson subsidiary McNeil-PPC owes $25 million.
The first contamination report came from a McNeil customer returned a bottle of Children's Tylenol in May 2009 because it contained "black specks," according to the government's information against the company.
Though lab tests showed that the product contained nickel and chromium, two materials that are not ingredients in the drug, McNeil failed to link the contamination to its manufacturing equipment, the U.S. government says.
Those metals are, however, part of the machinery McNeil used to manufacture children and infants' Tylenol and children's and infants' Motrin, at its plant in Fort Washington, Pa.
The government says McNeil did not implement a "Corrective Action Prevention Action," or CAPA, to address the contaminated medicine manufactured at its Fort Washington, Pa., plant until April 2010.
By that time, "McNeil itself [had] found particles in OTC liquid drugs during production at the Fort Washington plant" on three occasions, the plea agreement says, summarizing the allegations in the government's the information.
McNeil stopped production on one of its liquid lines after a fourth incident, on April 13, 2010, "when it found discolored OTC [over-the-counter] liquid drug product on the base of a liquid filler machine during production of Infants' Tylenol," the plea continues.
After the Food and Drug Administration uncovered various regulatory compliance failures that month, it helped McNeil institute a recall "all lots of certain unexpired infants' and children's OTC drugs manufactured at the Fort Washington plant," according to the plea.
All McNeil plants were placed under permanent injunction in 2011, and the Fort Washington plant where the incidents of contamination occurred remains closed.
The company is currently working to bring the plant into compliance.
In addition to a $20 million criminal fine, McNeil faces $5 million in criminal forfeiture.
McNeil has faced various civil lawsuits by consumers over the tainted medicine.
At least four parents, in Nevada , New York , Washington and Illinois , blame Tylenol for killing their children. -
Maker Of Children's Tylenol Contaminated With Metal Particles Pleads Guilty
Mar 11, 2015 | Yahoo! Health
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 late 2009, the company recalled Tylenol, Motrin, and Benadryl after consumers reported a moldy odor coming from newly opened bottles and complaints of stomach pains and diarrhea were filed.
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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Johnson & Johnson subsidiary to pay $25M fine over children's Tylenol recall
Mar 11, 2015 | UPI
By Danielle Haynes
A Johnson & Johnson subsidiary has agreed to pay a $25 million criminal fine associated with a recall in 2009 of over-the-counter liquid children's medicines that had particles in them.
McNeil-PPC Inc., a wholly owned subsidiary of Johnson & Johnson, pleaded guilty to one misdemeanor count of delivering into interstate commerce adulterated infants' and children's over-the-counter liquid medicines.
Those medicines were part of a recall that included tens of thousands of bottles of infants' and children's Tylenol and infants' and children's Motrin manufactured at the company's Fort Washington, Pa., facility. Customers complained of particles floating in the liquid. Those particles turned out to be small pieces of metal McNeil said didn't pose health or safety risks to consumers.
An FDA investigation into the facility after the recall revealed the medicine wasn't manufactured according to best practices and was in violation of the federal Food, Drug and Cosmetic Act.
"McNeil's failure to comply with current good manufacturing practices is seriously troubling," said Acting Assistant Attorney General Mizer. "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."
According to the court documents, McNeil failed to initiate a Corrective Action Preventive Action plan after first receiving complaints about the particles in May 2009.
"The law requires that drugs be produced under the most rigorous of quality standards," said First Assistant U.S. Attorney Lappen. "When companies fail to exercise the vigilance that the law demands, they will held be accountable. Drug companies should be aware that failing to adhere to good manufacturing practices subjects them to penalties and prosecution."
As part of its plea, McNeil agreed to pay a $20 million fine and forfeit $5 million.
"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 spokesperson for McNeil Consumer Healthcare. "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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Company behind Infant's Tylenol and Motrin to pay $25 million
Mar 11, 2015 | She Knows - Blog
By Monica Beyer
A company knew that they were producing contaminated children's medication, yet continued to make and sell it for another year — which is now costing them $25 million.
There was a major recall of Infant's Tylenol and Motrin in 2010, and now the company behind the products is paying big time. Why? Because they sold the medication, which was contaminated with metal particles, for a year after they discovered there was a problem.
McNeil Consumer Healthcare, which is a subsidiary of Johnson & Johnson, has agreed to pay $25 million after they pled guilty for selling the meds despite evidence of contamination. While no injuries were reported, the company's Pennsylvania plant introduced nickel, iron and chromium into millions of bottles, and even after evidence was brought to light, no changes were made and they continued to pump out contaminated meds for the next year.
Court documents revealed that the company became aware of the contamination in May 2009 after they received complaints of black specks within the liquid of the medication itself. The plant involved in pushing out the meds was closed shortly after the recall was announced, and while plans were made to reopen it, that has yet to happen.
In a statement, 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."
It's really disturbing that the issues were known for an entire year before the company decided to pull the reins, stop production and recall the medicine. While I don't specifically remember if I administered any to my youngest, who was a baby during the time the contaminated meds were in circulation, it makes me sick that they knew for 12 months that there was a problem and they didn't seem to care.
The company now carefully monitors the medicine that it produces with a higher level of quality control and more stringent testing, but it makes you wonder why medication that we give to our infants and children isn't already subject to the highest levels of testing there is.
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Tylenol Maker Admits To Selling Drugs Contaminated With Metals
Mar 11, 2015 | Tech Times
By Jim Algar
A subsidiary of Johnson & Johnson has pleaded guilty to selling liquid medications that had been contaminated with metal during the manufacturing process, the U.S. Department of Justice says.
McNeil Consumer Healthcare, the subsidiary, has agreed to pay a $25 million settlement after pleading guilty in a Federal District Court in Philadelphia to a single federal criminal charge, the manufacture and processing of adulterated over-the-counter medicines, the department announced.
Prosecutors said the company was aware of the problem for almost a year but failed to take timely steps to fix it.
"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," Acting Assistant Attorney General Benjamin C. Mizer said after a judge accepted McNeil's settlement plea.
In 2010, McNeil Consumer Healthcare issued a recall for over-the-counter medications, including Children's Motrin and Infants' Tylenol manufactured at its plant in Fort Washington, Pennsylvania.
In May 2009, a consumer complained about noticing "black specks" at the bottom of a bottle of Infants' Tylenol. The specks were later determined to be nickel and chromium particles.
The recall of Infant's Tylenol and Children's Motrin, which kept the widely-used medications off pharmacy shelves, followed a flurry of recalls between 2008 and 2010 that involved hundreds of millions of packages of Tylenol, Motrin, Benadryl and other consumer health products, all recalled for faulty manufacturing.
In addition to the metal particles making their way into liquid medicines, there were problems with mold odors and confusing labeling instructions.
In one instance, people who bought Sudafed allergy tablets found themselves reading label instruction that, because of incorrectly repeating the word "not," read as a confusing "do not not divide, crush, chew or dissolve the tablet."
The rash of recalls seriously tarnished Johnson & Johnson's reputation, and in 2010 the company lost an estimated $900 million in sales.
A McNeil Consumer Healthcare spokeswoman, Carol Goodrich, said the plea agreement and $25 million settlement "closes a chapter."
In addition, she said, the company has "been implementing enhanced quality and oversight standards across its entire business" and under the terms of the agreement with the Justice Department would put additional safety measures in place before reopening its manufacturing facility in Fort Washington.
Johnson & Johnson, headquartered in New Brunswick, New Jersey, has around 250 subsidiary companies operating in more than 57 countries, and its pharmaceutical and consumer health products are sold in over 175 countries.
McNeil Announcement - Media Coverage Report 3/11/15 - 7 PM
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