FOR IMMEDIATE RELEASE
NEWS RELEASE
July 29, 2015
For More Information, contact:
Luther Strange
Mike Lewis (334) 353-2199
Alabama Attorney General
Joy Patterson (334) 242-7491
Page 1 of 1
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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501 Washington Avenue * Montgomery, AL 36104 * (334) 242-7300
www.ago.state.al.us
