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Entries in Recalls (4)

Saturday
Jul272013

FDA Issues Warning About Potentially Dangerous Vitamin Supplement

Jupiterimages/Thinkstock(NEW YORK) -- The Food and Drug Administration has issued a warning about a vitamin supplement which reportedly contains two possible dangerous anabolic steroids.

The FDA wants consumers to avoid a Vitamin B dietary supplement from Healthy Life Chemistry by Purity First. The agency says the company's B-50 supplements tested positive for two steroids used by some bodybuilders illegally. Neither ingredient is on the product label.

According to the FDA, Healthy Life Chemistry has declined a government request for a voluntary recall of the product.

Copyright 2013 ABC News Radio

Wednesday
Oct102012

Kellogg Issues Mini-Wheat Recall

Hemera/Thinkstock(NEW YORK) -- Kellogg is recalling boxes of Mini-Wheats cereal due to the “unlikely but possible presence of fragments of flexible metal mesh from a faulty manufacturing part,” according to the company.

“Although there have been no reports of any injuries, Kellogg initiated a voluntarily recall of certain packages of Mini-Wheats Bite Size cereal as a precautionary measure,” company spokesman Kris Charles said in a statement. “At Kellogg, our number one priority is the quality and safety of our foods and we take this situation very seriously.”

The recall covers roughly 282,000 cases of Frosted Mini-Wheats Bite Size Original and Mini-Wheats Unfrosted Bite Size cereal with the letters KB, AP or FK before or after the best-before date. Most of the recalled products are cereal boxes, but some are single-serving bowls.

Kellogg consulted with David Acheson, an internal medicine doctor and former chief medical officer at the FDA Center for Food Safety and Applied Nutrition, who said the likelihood of metal fragments making their way into the food is low, according to a company statement.

“We are reassured that our increased supply chain investments helped us to quickly identify the root cause and our preventative maintenance program helped us mitigate the impact,” the company said.

The odds of any affected food causing injury are also low, according to the company.

Copyright 2012 ABC News Radio

Tuesday
Jun052012

US Has Drug Recall Problem, Study Says

Comstock/Thinkstock(BOSTON) -- Drug recalls in the U.S. happen frequently -- about once every month -- according to researchers at Brigham and Women’s Hospital in Boston.

In a new study published Monday in the Archives of Internal Medicine, the researchers found that although the U.S. Food and Drug Administration has systems for communicating these recalls, they might not be enough to warn health care providers of important drug recall information.

Researchers also found that the FDA issued official public notices for only about half of the recalls deemed the most serious, called Class I recalls.

”The FDA offers this communication service, and we anticipate that a lot of providers may rely on it and in doing so may not be getting the information they need when drugs are recalled,” said Joshua Gagne, an epidemiologist at Brigham and Women’s Hospital and one of the authors of the study.

Gagne and his colleagues analyzed eight years of data from the FDA’s Enforcement Reports and the archives of the agency’s two chief drug recall-reporting systems: the Recall Alert System and the FDA MedWatch Safety Alert database.  According to the study, FDA records show 1,734 drug recalls from 2004 to 2011; 91 of those recalls were tagged Class I recalls, meaning they had the greatest likelihood to cause patients serious harm, even death.

Of the 91 Class I recalls, the FDA issued official Recall Alert System notices for 55 of them.  For the remaining 36, half were reported through the FDA’s MedWatch system.  The remaining 18 Class I recalls were not communicated through either system.

Gagne also noted that the Recall Alert System is used also for recalls of products that have no bearing on patient care, such as veterinary drugs.

“It’s very possible that these important recalls are being lost in the less important ones,” Gagne said.

Responding to the article, FDA spokeswoman Sarah Clark-Lynn said the agency used many different methods of communicating information about drug recalls and safety, including email list serves, news releases, Twitter and text messaging.  And recalls, she said, were not up to the FDA alone.

“The recall system depends on full and open disclosure [by manufacturers], trust and the industry’s acceptance of its responsibilities to protect the public from violative products,” Clark-Lynn said in an email.

Gagne said the study didn’t look into how many times manufacturers notified physicians about drug recalls, which they frequently do via “Dear Doctor” letters sent directly to health care providers.

The researchers also found that drug recalls weren’t usually limited to a few pills here and there.  Of the Class I recalls from 2004 to 2011, 34 percent affected more than 100,000 units of a drug, and 64 percent of recalled drugs had been distributed nationwide.  Forty percent of the recalls were because of contaminated drugs, and 25 percent of the drugs were recalled for having the wrong doses or release mechanisms.  The rest were the result of product mix-ups or mislabeling.

Copyright 2012 ABC News Radio

Wednesday
Dec282011

Chicken Treats May Have Sickened Hundreds of Dogs

iStockphoto/Thinkstock(WASHINGTON) -- Over the past month, the U.S. Food and Drug Administration has received more than 200 reports of dogs being sickened -- some fatally -- after eating chicken jerky treats imported from China.

On Nov. 18 the FDA warned it had received an increase in complaints of illnesses in dogs that had eaten chicken jerky -- tenders, strips and treats. At that point, there had been 70 reports.

Since then, the agency has received another 283 reports. That brings the total to 353 pets sickened. Some of them died, but the FDA has not released a number of deaths.

Investigators have not yet directly linked the illnesses to eating the treats and contaminants have not yet been found on any particular product.

An FDA spokeswoman writes: “A specific brand hasn't been identified nor a causal relationship established between the chicken jerky products and the reports of illnesses/deaths. The FDA is actively investigating the matter and conducting analysis for multiple different chemical and microbiological contaminants. We have tested numerous samples of chicken jerky products for possible contaminants including melamine. The complaints received have been on various chicken jerky products but to date we have not detected any contaminants and therefore have not issued a recall or implicated any products. We are continuing to test and will notify the public if we find evidence of any contaminants.”

The FDA spokeswoman also says, “It's also important to note that not all complaints have been triaged and categorized yet at to what types of symptoms.”

Copyright 2011 ABC News Radio







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