FDA widens Tylenol probe

By Parija Kavilanz, senior writer


NEW YORK (CNNMoney.com) -- The Food and Drug Administration said Monday it is expanding its investigation of a Johnson & Johnson manufacturing division tied to the recent recall of children's drugs.

On May 1, Johnson & Johnson's McNeil Consumer Healthcare unit recalled some 50 children's versions of non-prescription drugs, including Tylenol, Motrin and Benadryl.

Then on May 6, the FDA issued a scathing 17-page inspection report of McNeil's Fort Washington, Pa., plant that produced the drugs.

Now the FDA is conducting a companywide investigation of McNeil's "manufacturing practices to determine whether similar problems exist throughout the company and what additional steps the agency must take to ensure that these problems do not recur," according to a statement posted Monday on the FDA website.

In a statement e-mailed to CNNMoney on Monday, McNeil said the company "is conducting a comprehensive quality assessment across its manufacturing operations and continues to cooperate with the FDA."

Johnson & Johnson (JNJ, Fortune 500), which subsequently shut the Fort Washington facility, has declined to disclose what other products are manufactured at the plant.

In announcing the recall, McNeil said that some of the children's products may contain incorrect concentration of ingredients, ingredients that don't meet testing requirements and tiny metal particles.

The FDA on Monday declined to comment on how many other facilities it is targeting in the expanded probe.

A McNeil plant in Puerto Rico that makes adult versions of over-the-counter drugs was the focus of a recall in January after the company got complaints of an "unusual moldy, musty or mildew-like" odor in products made at the plant.

The FDA's May 6 report about the Fort Washington plant listed 20 violations. In one of them, the agency said McNeil had taken no action after receiving 46 consumer complaints on the recalled products.

The company and the FDA have said that the recalled children's drugs pose a "remote" potential for serious health problems.

A congressional committee has opened an investigation into the recall.

The House Committee on Oversight and Government Reform has scheduled a hearing on May 27 to examine the recall. The panel said it had invited Johnson & Johnson Chief Executive William Weldon to testify.

Johnson & Johnson spokesman Jeff Leebaw said the drugmaker is "communicating with the committee and will respond appropriately to its request."  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 16,805.41 127.51 0.76%
Nasdaq 4,483.72 30.92 0.69%
S&P 500 1,964.58 13.76 0.71%
Treasuries 2.27 -0.00 -0.09%
Data as of 11:05pm ET
Company Price Change % Change
Ford Motor Co 13.78 -0.62 -4.31%
Microsoft Corp 46.13 1.11 2.47%
Apple Inc 105.22 0.39 0.37%
Bank of America Corp... 16.72 0.12 0.72%
Yahoo! Inc 43.50 0.90 2.11%
Data as of Oct 24

Sections

New York headlines took a straight forward and direct approach with NYC's Ebola news. More

The midterm elections are around the corner, and the economy remains a top concern. With unemployment down and inflation low, why do people still feel the economy stinks? More

Shares of Facebook recently topped $80. They've more than quadrupled from their post-IPO lows of two years ago. Can Mark Zuckerberg keep the momentum in mobile going? More

Host a furniture market. Here's how small town High Point, N.C. rakes in this much money -- twice a year. More

If you're looking to fly this holiday season, the clock's ticking to get the best prices. More

Most stock quote data provided by BATS. Market indices 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.

Factset: FactSet Research Systems Inc. 2014. All rights reserved.

Chicago Mercantile Association: Certain market data is the property of Chicago Mercantile Exchange Inc. and its licensors. All rights reserved.

Dow Jones: The Dow Jones branded indices are proprietary to and are calculated, distributed and marketed by DJI Opco, a subsidiary of S&P Dow Jones Indices LLC and have been licensed for use to S&P Opco, LLC and CNN. Standard & Poor's and S&P are registered trademarks of Standard & Poor’s Financial Services LLC and Dow Jones is a registered trademark of Dow Jones Trademark Holdings LLC. All content of the Dow Jones branded indices © S&P Dow Jones Indices LLC 2014 and/or its affiliates.