Tylenol maker pledges quality overhaul

By Parija Kavilanz, senior writer


NEW YORK (CNNMoney.com) -- Drugmaker McNeil Consumer Healthcare, currently under investigation by the Food and Drug Administration following a string of recalls related to its over-the-counter drugs including Tylenol, Motrin and Benadryl, outlined steps Tuesday to remedy serious quality and safety lapses at its manufacturing facilities.

"McNeil is taking steps to bring its operation back to a level of quality that Johnson & Johnson demands of its companies, and that the public rightly expects of us, and that we expect of ourselves," the company said in a statement.

McNeil, a division of Johnson & Johnson (JNJ, Fortune 500), has initiated four recalls of its products in the past seven months, including a widespread recall of children's non-prescription drugs on May 1. Johnson & Johnson has suspended production at McNeil's Fort Washington plant that manufactured the children's products. Johnson & Johnson also faces Congressional hearings on Thursday about McNeil's product recalls.

Among the measures, the drugmaker said it has hired an independent pharmaceutical consulting firm to identify corrective actions to improve quality and manufacturing systems at its Fort Washington facility. The company said it is improving employee training in every part of the manufacturing and quality operations, and implementing new processes for conducting investigations on quality levels.

McNeil also said the company has made significant organizational changes but did not provide details about the changes.

Additionally, the company said it is working with an independent consultant on specific steps to improve overall quality during it what it termed as a "remediation" period, but did not specify its time frame. McNeil also did not say when it would resume production at the Fort Washington plant which makes all of the company's pediatric liquid medications.

During the remediation period, McNeil said it will establish a steering committee of senior management to oversee efforts across the company. Also, each manufacturing facility will also have a remediation committee responsible for implementing the plan for that plant and monitoring its effectiveness.

McNeil said it was enhancing its "good manufacturing practices" training program for all employees and would conduct a full assessment of the processes, equipment, and facility at its Fort Washington and other plants.

Regarding its products, McNeil said it will conduct in-depth quality assessments for each product that the company manufactures to "ensure each product's ability to meet specifications throughout its shelf life."

Further, the company said it will update the FDA about its progress implementing the plan at least once a month and would involve an independent firm in making product decisions during the first six months of operation. Third-party involvement could also include review of investigations, complaints, completed batch records, and changes that have the potential to affect products or processes. the company said. To top of page

Frontline troops push for solar energy
The U.S. Marines are testing renewable energy technologies like solar to reduce costs and casualties associated with fossil fuels. Play
25 Best Places to find rich singles
Looking for Mr. or Ms. Moneybags? Hunt down the perfect mate in these wealthy cities, which are brimming with unattached professionals. More
Fun festivals: Twins to mustard to pirates!
You'll see double in Twinsburg, Ohio, and Ketchup lovers should beware in Middleton, WI. Here's some of the best and strangest town festivals. Play
Index Last Change % Change
Dow 16,982.59 22.02 0.13%
Nasdaq 4,444.91 0.00 0.00%
S&P 500 1,978.91 0.57 0.03%
Treasuries 2.49 0.02 0.89%
Data as of 3:59am ET
Company Price Change % Change
Apple Inc 99.02 1.99 2.05%
Facebook Inc 74.92 -0.06 -0.08%
Bank of America Corp... 15.50 -0.09 -0.58%
Dollar Tree Inc 54.87 -0.08 -0.15%
Family Dollar Stores... 75.74 15.08 24.86%
Data as of Jul 28

Sections

Herbalife shares tumble after the maker of nutritional supplements reports earnings that fall short of analysts' estimates. More

New annual report from U.S. government shows the long-term prognosis for Medicare has improved thanks to slower health spending, while the outlook for Social Security remains unchanged. More

Online dating site OkCupid found its users were more likely to have conversations when it told them they were more compatible than in reality. More

Actor-founded This Bar Saves Lives had Hollywood connections, but learned Start-Up 101 the hard way. More

Steve Mason, a pastor from California, inherited more than $100,000 in student loan debt when his 27-year-old daughter died suddenly in 2009. With interest and late penalties, the debt has since ballooned to $200,000. More

Market indexes are shown in real time, except for the DJIA, which is delayed by two minutes. All times are ET. Disclaimer Morningstar: © 2014 Morningstar, Inc. All Rights Reserved. Disclaimer The Dow Jones IndexesSM are proprietary to and distributed by Dow Jones & Company, Inc. and have been licensed for use. All content of the Dow Jones IndexesSM © 2014 is proprietary to Dow Jones & Company, Inc. Chicago Mercantile Association. The market data is the property of Chicago Mercantile Exchange Inc. and its licensors. All rights reserved. FactSet Research Systems Inc. 2014. All rights reserved. Most stock quote data provided by BATS.