FDA warns another drugmaker over tainted meds

By Blake Ellis, staff reporter


NEW YORK (CNNMoney.com) -- You may have thought you were playing it safe by avoiding recently-recalled Johnson & Johnson products, but another drugmaker is now in the hot seat for some of the same problems, including the release of metal-tainted pills.

On Thursday, the U.S. Food and Drug Administration issued a warning letter to one of the world's largest manufacturers of generic drugs, Michigan-based Perrigo Co.

The FDA said Perrigo failed to take appropriate action after the FDA cited the drug maker with a number of violations following an inspection of its facilities earlier in the year.

The first violation was issued for releasing products that didn't meet quality control standards, including ibuprofen tablets contaminated with metal shavings from an equipment failure, the FDA said.

"Although your firm segregated a portion of the lot that was affected, you released and shipped a subportion of that segregated lot, resulting in a recall of the entire lot," Joan Givens, director of the FDA's Detroit District Office said in the letter.

The FDA also cited Perrigo for failing to correct and verify label content, for not adequately inspecting its facilities and for failing to thoroughly investigate the possible contamination of some of its products, such as why certain ibuprofen tablets weren't the same size.

While the drugmaker responded to the citations back in February, the response was not adequate, Givens said.

"Your response does not provide the corrective actions your firm plans to take to prevent reoccurrences in the future," she said.

Perrigo has 15 days from the receipt of Thursday's letter to explain to the FDA what steps it has taken to address these violations, the agency said in the letter.

"We are continuing to work with the FDA to ensure corrective actions are in order and approved in all areas of the investigation," said Perrigo spokesman Arthur Shannon.

The FDA's letter comes the same day agency officials testified at a Congressional hearing about Johnson & Johnson's recent series of recalls, one of which also involved possible metal contamination of its children's Tylenol pills.

Despite the FDA's warning,Perrigo (PRGO) still managed to eke out gains in Thursday trading, rising 4% to $60.24, while Johnson & Johnson (JNJ, Fortune 500) fell 0.15% to $59.03. 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 -4.65 -0.10%
S&P 500 1,978.91 0.57 0.03%
Treasuries 2.49 0.02 0.89%
Data as of 9:37pm ET
Company Price Change % Change
Apple Inc 99.02 1.35 1.38%
Facebook Inc 74.92 -0.27 -0.36%
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 4:03pm ET

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.