AG Strange Announces Settlement Regarding Quality Control and Possible Recalls of Drugs

NEWS RELEASE
Luther Strange
Alabama Attorney General www.ago.alabama.gov

For More Information
Contact:
Mike Lewis (334) 353-2199
Joy Patterson (334) 242-7491
Claire Haynes (334) 242-7351

FOR IMMEDIATE RELEASE

 July 29, 2015

AG STRANGE ANNOUNCES SETTLEMENT REGARDING QUALITY CONTROL AND POSSIBLE RECALLS OF DRUGS

(MONTGOMERY)—Attorney General Luther Strange today announced a settlement between the State of Alabama and McNeil-PPC Inc., a subsidiary of Johnson and Johnson, regarding policies about the quality of over-the-counter drugs (OTC) and possible recalls.

The settlement is the result of an investigation concerning a “phantom recall” of Children’s Motrin that the company allegedly conducted in 2009.  It was reported that certain lots of the drug were found to be substandard, and that instead of conducting an open recall, the company sent teams of people to surreptitiously buy and remove all of the product remaining in stores.

Under the settlement, the company will be required to follow certain protective procedures to prevent any possible recurrence. It will be forbidden to represent that its facilities meet “Good Manufacturing Practices” of the Food and Drug Administration (FDA) if there has been a recall of ingestible over-the-counter drugs within the last 12 months at the facilities that were the subject of the investigation. Additionally, the company is ordered to follow strict procedures on whether a “Corrective Action/Preventive Action” should be undertaken in its manufacture of OTC drugs.  Also, the company will pay $500,000 to the State of Alabama for attorneys’ fees and other costs of investigation.  

“The allegations from which this investigation arose are of serious concern,” said Attorney General Strange.  “Consumers need to have confidence in the quality control of over-the-counter drugs that they buy for their families.  This settlement helps to ensure that the alleged conduct does not occur in the future.”

Attorney General Strange commended those involved in the successful settlement of this matter, noting in particular Assistant Attorneys General Kyle Beckman and Noel Barnes, chief, of his Consumer Litigation Section. 

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