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Families of Victims of Contaminated Heparin Testify Before Congress

Apr 29, 2008 4:20:22 PM

Heparin is used in medicine as an anti-coagulant; that is, it stops blood from clotting. Because of this effect, the drug is often used to prevent blood or plasma clotting in or on medical devices such renal dialysis machines. 

In March 2008, the FDA announced major recalls of heparin imported from China due to contamination. Today, families of victims who died from exposure to contaminated heparin while undergoing dialysis testified before a Congressional subcommittee investigating the recall. The subcommittee also heard from Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, who indicated that initial evidence shows the contamination was intentional, and not a manufacturing mistake.

The Washington and Oregon medication error lawyers at D'Amore & Associates help clients and their families obtain compensation for injury resulting from being prescribed the wrong drug, or from drug side effects.

FDA Video Series Covers Recalls and Safety Alerts for Prescription Drugs and Medical Devices

Apr 14, 2008 12:01:00 AM

The FDA's Patient Safety News (PSN) is a series of monthly video news shows addressing significant approvals, recalls, and safety alerts for prescription drugs and medical devices. Some of the videos contain footage and demonstrations relevant to protecting patients from serious side effects and other unwanted consequences from taking or using these products.

For example, consumers may want to watch the video concerning the recent FDA warning against giving cough and cold medicines to young children.

Click here for access to the full list of currently available videos (note: the videos are primarily targeted at doctors and other healthcare professionals and thus may be somewhat technical in nature).

Harry and David Issues Nationwide Allergy Alert on Undeclared Milk in Harry and David Chocolate Covered Select Blend Espresso Beans

Apr 5, 2008 11:51:38 PM

Last week, the FDA issued a press release notifying the public that Harry and David, of Medford, Oregon, is voluntarily recalling approximately 66,500 8 oz. bags of Harry and David Chocolate Covered Select Blend Espresso Beans because they may contain milk not declared on the ingredient statement. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

Consumers with product may return it to any Harry and David retail store for a full refund.

Click here to read the full FDA press release.

Nationwide Recall of Cantaloupes From Honduran Packer Underway Due to Salmonella Risk

Apr 1, 2008 9:34:00 AM

In late March, the FDA announced a nationwide recall of cantaloupes grown, packed and shipped by an independent third-party grower in Honduras. The product was distributed nationwide and in Canada. Based on current information, the cantaloupe grown, packed and shipped from the grower, Agropecuaria Montelibano, appears to be associated with a salmonella outbreak in the United States and Canada.

In persons with poor health or weakened immune systems, salmonella can invade the bloodstream and cause life-threatening infections. Symptoms of food-borne Salmonella infection include nausea, vomiting, fever, diarrhea, and abdominal cramps. Individuals who have recently eaten cantaloupe and experienced any of these symptoms should contact their health care professional.

The FDA advised consumers who have recently bought cantaloupes to check with the place of purchase to determine if the fruit came from the identified grower. If so, consumers should throw away the cantaloupes.

FDA Launches Consumer E-mail Alert Service Covering Product Recalls and Other News

Dec 10, 2007 12:44:00 AM

Earlier this month, the FDA announced the launch of an email alert service that alerts subscribers whenever information is updated on certain FDA Web pages.

The list of available topics includes medical and other product safety alerts and recalls.

We encourage readers to sign up (note: the process is a little cumbersome - you must first sign up for one topic, but then once signed up, you can update your email address using a checklist to add additional topics for notification).

Harry & David Recall

Dec 3, 2007 1:04:33 PM

Harry & David recalls Harry and David Moose Munch® Confection Tubs in Two Flavor Combinations: Milk & Dark Chocolate, White Chocolate Macadamia and Peanut Butter, Milk Chocolate, Macadamia Nut for Undeclared Nut Allergen.

http://www.fda.gov/oc/po/firmrecalls/harrydavid11_07.html

Contact:
Mr. Bill Ihle
         541 864-2145       (Media Calls Only)

FOR IMMEDIATE RELEASE -- Medford, OR -- November 21, 2007--- Harry & David Operations Corp., of Medford, Oregon, is voluntarily recalling approximately 5880 tubs of the Milk & Dark Chocolate, White Chocolate Macadamia because they may contain macadamia nuts not declared on the ingredient statement, and 4400 tubs of the Peanut Butter, Milk Chocolate, Macadamia Nut because they may contain macadamia nuts and peanuts not declared on the ingredient statement. People who have an allergy or severe sensitivity to these nuts (macadamia or peanut) run the risk of serious or life-threatening allergic reaction if they consume these products.

The products are packaged in 1 lb. 10 oz clear plastic tubs containing three flavors of Moose Munch ® Confection, a caramel corn and chocolate confection.

Harry & David is recalling all Milk & Dark Chocolate, White Chocolate Macadamia with a nutrition label that states Milk Chocolate, Caramel, Dark Chocolate at the top. The potentially affected lot codes are lot codes 304 NXXX NN:NN, 305 NXXX NN:NN, 306 NXXX NN:NN or 307 NXXX NN:NN. In the lot number on the plastic tub, the X is a letter and N is a number.

Harry & David is recalling all Peanut Butter, Milk Chocolate, Macadamia Nut with a nutrition label that states Milk Chocolate, Caramel, Dark Chocolate at the top. The potentially affected lot codes begin with 264 NXXX NN:NN, 265 NXXX NN:NN or 266 NXXX NN:NN. In the lot number on the plastic tub, the X is a letter and N is a number.

The lot codes are ink jetted on the sides of the tubs in black ink.

The Milk & Dark Chocolate, White Chocolate Macadamia was produced from October 31 through November 3 rd, 2007, and was distributed exclusively throughout the United States in Harry and David Stores, beginning on November 9, 2007. The Peanut Butter, Milk Chocolate, Macadamia Nut was produced from September 21st through September 23rd, 2007, and was distributed exclusively throughout the United States in Harry and David Stores, beginning on October 10, 2007.

There have been no injuries reported to date. Anyone concerned about a potential illness associated with this product should contact a physician immediately. This problem occurred when tubs with nutrition labels for another product were used for these items.

Consumers with questions about the recalled product may phone the Customer Service division at 800- 233-1101, 24 hours a day. Customers may arrange for refunds through this number as well.

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http://www.fda.gov/oc/po/firmrecalls/harrydavid11_07.html