Tag Archives: tylenol

Factory that made recalled Tylenol was cited

The U.S. House of Representatives’ oversight committee will hold a hearing today about an April 30 recall of children’s Tylenol and other medicines. In advance of that hearing, Alison Young of USA Today reports that the manufacturing place responsible for the medicine “was cited last year by regulators for ‘knowingly’ using a bacteria-tainted ingredient, according to a 2009 inspection report.”

The U.S. Food and Drug Administration also cited the McNeil Consumer Healthcare plant for a similar violation last month. The April inspection, which found serious manufacturing violations and drugs that were potentially too potent, prompted the current recall.

Young also reports that the FDA issued 43 warning letters since January 2009 to drug factories about poor practices that may have endangered patients.

Violations serious enough to prompt warning letters from the U.S. Food and Drug Administration include plants using equipment and ingredients contaminated with bacteria or insects, failing to do proper testing to ensure drug strength and purity, and ignoring consumer complaints that products were making them sick.

Among the cases Young cites are possible bacterial contamination of propofol, reports of bug parts in another company’s medicines and bacteria in calcium carbonate, which is used in antacids and a menopause drug.

That House hearing starts at 10 a.m. ET and will be webcast. To watch, click here.

NPR’s Scott Hensley has been staying on top of the recall story on the Shots blog.

(Hat tip to the Donald W. Reynolds Center for Business Journalism)

FDA weighs tougher warnings for acetaminophen

When it comes to acute liver damage, acetaminophen, the painkilling ingredient in Tylenol, is a bigger hazard than alcohol.


Photo by sun dazed via Flickr

Some 56,000 Americans end up in the ER each year as a result of the drug, a ubiquitous ingredient in over-the-counter cough and cold remedies and also one half of the most prescribed medicine in the United Stateshydrocodone-APAP.

So the Food and Drug Administration, which has ratcheted up warnings about acetaminophen’s risk in recent years, is holding a two-day meeting seeking advice on what to do next.

For consumers, a big part of the problem is that taking even a little more than the highest recommended daily dose (4 grams for adults) can lead to serious liver damage.

About half the nearly 500 annual cases of liver failure linked to acetaminophen are accidental. It’s easy to overlook the total dose of acetaminophen when taking a pain pill and a combination medicine, for instance.

One option would be a ban on combination drugs, like Theraflu and NyQuil. Makers of over-the-counter drugs say prescription-strength medicines containing acetaminophen account for most of the problems.

The outcome of the meeting will be “an important first test of the FDA’s new power to impose risk evaluation and mitigation strategies on manufacturers of widely used drugs that pose a small but distinct public health threat when misused or abused,” writes FDA-watcher Merrill Goozner on the blog GoozNews.