J&J OTC Drugs Did Not Meet Quality Requirements. Johnson & Johnson (J&J) has reached a $33 million settlement with 42 states, resolving allegations the health giant sold numerous nonprescription, or over-the-counter (OTC) medicines that did not meet federal quality requirements. Attorneys general in those state, including Pennsylvania, and the District of Columbia, announced the civil settlement with Tylenol maker McNeil-PPC, a J&J subsidiary to resolve allegation that the company distributed contaminated OTC medications and made false or misleading representations about the products.
Pennsylvania’s share will be $1.4 million, which will be used to fund future consumer protection efforts, said Attorney General Josh Shapiro. McNeil, based in Fort Washington, Montgomery County, recalled hundreds of millions of packages of drugs manufactured between 2009 and 2011, Shapiro said. New Jersey is slated to receive $1 million as part of the agreement, Philly.com reports.
Recalled OTC Drugs
Complaints about products made at J&J factories in Puerto Rico and suburban Philadelphia, included strange odors, particles found in liquid medicines, and wrong ingredient levels. The recalled drugs – some for infants and children – included Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Sudafed, Pepcid, Mylanta, Rolaids, Zyrtec, and Zyrtec Eye Drops. McNeil is now part of Johnson & Johnson Consumer Inc.
A prior investigation by the U.S. Department of Justice (DOJ) into McNeil’s quality-control issues resulted in a misdemeanor guilty plea in March 2015, a criminal fine of $20 million, and forfeiture of an additional $5 million.
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Allegations Cited by Attorneys General
Pennsylvania and Texas headed an executive committee that investigated the McNeil allegations, Shapiro said. Other attorneys general represented were Alaska, California, Massachusetts, Pennsylvania, Florida, Texas, New York, Delaware, Kentucky, and others. The settlement resolves allegations that McNeil and J&J falsely promoted the products as having met federal standards when the FDA had cited some McNeil facilities, including Pennsylvania, between 2009 and 2011 for not meeting federal practices for good manufacturing.
“Johnson & Johnson’s disregard for proper manufacturing practices of children’s medications was unacceptable,” Illinois Attorney General Lisa Madigan said in a statement. “This settlement will shed light on this failure and serve as a reminder for all companies to follow the manufacturing processes required by law,” reports Law360.
“Those recalls were precautionary and not undertaken on the basis of any health or safety risks to consumers, and we remain committed to providing consumers with safe and effective over-the-counter medicines.”
The attorneys general stated that they filed a complaint alleging that J&J, acting through McNeil, violated state consumer protection laws by “misrepresenting its compliance with federal good manufacturing practices and the quality of the OTC drugs and by representing that those drugs had approval, characteristics and other qualities that they did not have,” according to Law360.
Temporary Website Restrictions
J&J is barred from stating on its websites that J&J’s over-the-counter drug facilities are compliant with good manufacturing practices if the company has had a recall of such products in the last year. It also must not state otherwise if it has not followed its internal standard of operating procedures about when to initiate a corrective action during manufacturing, and if they fail to inform the state attorneys general within 60 days of a request concerning the identity of the wholesalers or warehouses connected to a recalled drug that was distributed in their state.
“It’s essential that people who buy and consume these products be able to do so with confidence and without fear that they may be tainted in some way, or manufactured in substandard facilities,” New Jersey Attorney General Christopher Porrino said.
New Brunswick-based J&J is the world’s biggest health care company, with annual revenue of $71.9 billion, according to app.com.
It has been working on recovering from a series of high-profile missteps. Among them, is McNeil subsidiary, which makes popular OTC drugs such as Tylenol, and recalled 1,800 product lots between 2009 and 2011.
The company had agreed to temporarily close its plant in Fort Washington, Pennsylvania, and it agreed to tighter overseeing at other plants in Pennsylvania and Puerto Rico. J&J reopened its Fort Washington plant after it was notified that it was in compliance, in August 2015.
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