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Thread: FDA Alerts and Recalls...

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    FDA Alerts and Recalls...

    Harry & David Expands Its Nationwide Allergy Alert for Undeclared Nut Allergens in Candies

    Contact:
    Harry & David Operations Corp.
    800-345-5655

    FOR IMMEDIATE RELEASE -- Medford, OR -- April 13, 2007 -- Harry & David Operations Corp., of Medford, Oregon, is recalling approximately 2000 boxes of candies because they may contain undeclared nuts, including peanuts, almonds, pecans, walnuts and cashews.People who have an allergy to these nuts run the risk of serious or life-threatening allergic reaction if they consume these products.

    Harry & David is recalling all lot codes of these products. These products are in: 6 oz. paperboard boxes with a folded over top. The boxes are striped in several color variations.

    Dark Chocolate Clusters The Ultimate Walnut Cherry Caramel Indulgence candies in green and cream striped boxes (260).
    Dark Chocolate Clusters The Ultimate Peanut & Peanut Butter Indulgence in red and cream striped boxes (275).
    Dark Chocolate Clusters The Ultimate Pecan Cranberry Caramel Indulgence in dark red and cream striped boxes (270).
    Whole Almond Confection in brown and white striped boxes (595).
    Whole Cashew Confection in dark red and cream striped boxes (575).
    Sales of these products have ceased. The candies were produced and packaged by a third party vendor and distributed throughout the United States through Harry and David Stores beginning March 2007.

    There have been no injuries reported to date. Anyone concerned about a potential illness associated with this product should contact a physician immediately.

    The recall was initiated after it was determined that the products may contain undeclared nuts, including peanuts, almonds, walnuts, pecans and cashews. Harry and David has informed FDA of its action and is fully cooperating with the agency. Investigation into the cause is ongoing.

    Consumers are requested to return product to the place of purchase for a full refund. Consumers with questions about the recalled product may phone the Customer Service division at 800-233-1101, 24 hours a day.

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    : FDA Alerts and Recalls...

    Jen-On Herbal Science International, Inc. Issues A Voluntary Nationwide Recall of H S Joy of Love, a Product Marketed as a Dietary Supplement

    Contact:
    Dr. William Chang
    (626) 333-9998

    FOR IMMEDIATE RELEASE -- City of Industry, CA -- April 17, 2007- Jen-On Herbal Science International, Inc. 205 Russell St., City of Industry, CA 91744, announced today that it is conducting a voluntary nationwide recall of the company's supplement product sold under the name H S Joy of Love. Jen-On Herbal Science International, Inc. is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of H S Joy of Love samples found the product contains Piperadino Vardenafil, an analog of Vardenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). Piperadino Vardenafil is close in structure to Vardenafil and is expected to possess a similar pharmacological and adverse event profile. This poses a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

    H S Joy of Love is sold nationwide. The H S Joy of Love product is sold as a 12-capsule blister pack packaged in a retail box.

    Consumers who have H S Joy of Love in their possession should stop using it immediately. In the event of any adverse side effects due to its consumption, consumers should contact a physician right away. Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

    The company advises that any unused portion be returned to Jen-On Herbal Science International, Inc. for a full purchase price refund by calling (626) 333-9998 for instructions on the return and refund process.

    No illnesses have been reported to the company to date in connection with this product.

    Jen-On Herbal Science International, Inc. apologizes for any inconvenience and expresses its concerns for the health of consumers by conducting a voluntary recall action. Jen-On Herbal Science International, Inc. promises to ensure quality and integrity of all its products and the company is working closely with the FDA in the recall process.

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    : FDA Alerts and Recalls...

    Agriculture Department Warns Consumers of Tainted Raw Milk Sold by Butler County Dairy

    Contact:
    Chris L. Ryder
    (717) 503-0035 (cell)

    FOR IMMEDIATE RELEASE -- Harrisburg, PA -- April 13, 2007 -- Consumers who have purchased raw milk from Fisher's Dairy, Butler County, any time after April 9, 2007, should discard it immediately due to the risk of Listeria monocytogenes contamination, Agriculture Secretary Dennis Wolff said today.

    "During routine inspection, a preliminary test showed the presence of Listeria bacteria in some of the raw milk samples taken from Fisher's Dairy," said Wolff. "If consumers have raw milk from this farm, they should discard it immediately."

    There have been no illnesses reported because of the potential contamination, but if individuals who consumed the raw milk become ill, they are advised to consult their physician.

    Raw milk is milk that has not been pasteurized or homogenized.

    The Department of Agriculture has suspended sales of raw milk at the dairy and is ensuring that corrective action is taken. Samples taken from the farm during routine testing on April 9 tested positive for Listeria on April 13.

    Multiple laboratory samples must come back negative before sales can resume.

    Symptoms of Listeriosis are fever, muscle aches, and sometimes gastrointestinal symptoms such as nausea or diarrhea. If infection spreads to the nervous system, symptoms such as headache, stiff neck, confusion, loss of balance or convulsions can occur.

    Infected pregnant women may experience only a mild, flu-like illness, but infections during pregnancy can lead to miscarriage or stillbirth.

    Symptoms of Listeriosis can appear in four days to three weeks.

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    : FDA Alerts and Recalls...

    Vi-Jon Issues Voluntary Nationwide Consumer Recall of Alpine Xtreme Evergreen Forest Body Wash

    Contact:
    Barb Pierce/Ashley Gammon
    314-569-7100

    FOR IMMEDIATE RELEASE -- ST. LOUIS, April 19, 2007 - Vi-Jon, Inc. issued a voluntary nationwide consumer product recall of a single lot of 28 fluid ounce bottles of Alpine Xtreme Evergreen Forest Body Wash after determining the presence of a bacteria, Enterobacter gergoviae, in some of the product samples tested. The company became aware of this after determining that some of the product had become cloudy in appearance. An investigation concerning the cause of the issue is ongoing.

    After conducting a thorough assessment, the company concluded that the risk of illness in healthy individuals following use of this product is very low. However, there could be an increased health risk of small wound, skin or more serious infections to individuals with cuts, scrapes, rashes or other compromised skin conditions, or weakened or suppressed immune systems. There have been no consumer adverse health events reported that are related to this issue.

    The only affected product is Alpine Xtreme Evergreen Forest Body Wash, which is green in color. The Lot Code involved in this recall is 286071; identified by the first six numbers printed on the back of the bottle between the pump and the top of the back label. The recall docs not affect any other Alpine Xtreme Body Wash product. Consumers should discontinue using and properly discard the product, and may obtain a full refund through calling the company's toll-free consumer line, 1-888-593-0593, and mailing in the back label, including the UPC code. Additional information can be found at the product website, www.alpinextreme.net.

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    : FDA Alerts and Recalls...

    PET FOOD Up-To-Date RECALL LIST --

    http://www.accessdata.fda.gov/scripts/petfoodrecall/

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    : FDA Alerts and Recalls...

    Wilton Industries Issues Nationwide Allergy Alert on Undeclared Milk in Wilton Brand Dark Cocoa Candy Melts

    Contact:
    Wilton Industries
    1-866-255-9237

    FOR IMMEDIATE RELEASE -- Woodridge, IL -- April 20, 2007 -- Wilton Industries of Woodridge, Illinois is recalling WILTON PREMIUM DARK COCOA CANDY MELTS, WILTON DARK COCOA CANDY MELTS AND WILTON DARK COCOA MINT FLAVORED CANDY MELTS because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. The recall includes all production codes.

    These products were distributed nationwide and in Canada through retail stores and directly to customers.

    The Wilton Premium Dark Cocoa Candy Melts comes in 12 ounce plastic packaging. Wilton Dark Cocoa Candy Melts and Wilton Dark Cocoa Mint Flavored Candy Melts come in 14 ounce plastic packaging. 3 allergic reactions have been reported to date in connection with this problem.

    The recall was initiated after it was discovered that the milk-containing product was distributed in packaging that did not reveal the presence of milk. Wilton is working with the FDA to correct the problem.

    Consumers who have purchased packages of Premium Dark Cocoa Candy Melts, Dark Cocoa Candy Melts and Dark Cocoa Mint Flavored Candy Melts are urged to return them to Wilton Industries, Attention Returns Department, 1125 West Taylor Road, Romeoville, IL 60446 for a full refund. Consumers with questions may contact Wilton Industries at 1-866-255-9237.

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    : FDA Alerts and Recalls...

    ResMed Issues a Voluntary Recall for Certain 58 Flow Generators

    Contact:
    Hillary Theakston
    858-746-2610

    FOR IMMEDIATE RELEASE -- San Diego, CA, April 23, 2007 — ResMed today announced a worldwide voluntary recall of approximately 300,000 of its early production S8 flow generators used for the treatment of obstructive sleep apnea. In S8 devices manufactured between July 2004 and May 15, 2006, there is a remote potential for a short circuit in the power supply connector. ResMed plans to work with its distribution partners globally to provide a replacement device to patients who have an affected S8 flow generator.

    Patients may continue to use their S8 flow generators until they receive a replacement device. As with any electrical device, patients should make sure that it is placed on a hard clean surface and that the area around the device is clear during use. Patients should discontinue use of the device if there are any signs of electrical failure such as intermittent power, cracking sounds, sparking or charred smell. Patients should not use supplemental oxygen with an affected device; patients using supplemental oxygen should immediately contact their home healthcare provider for a replacement.

    The recall includes the following serial number ranges for all S8 models:

    From
    To

    20040285613
    20060269563

    20060275728
    20060276751

    20060277160
    20060277415

    20060281672
    20060281991

    20060283424
    20060283743

    20060284896
    20060285445

    20060287568
    20060290823

    20060292360
    20060294694

    20060312361
    20060312597

    20060318692
    20060319459

    20060325074
    20060327794

    20060330588
    20060331043

    ResMed voluntarily recalled the product after learning that in rare instances — less than two tenths of one percent (0.2%) — a short circuit in the power supply connector, a component supplied by a third party, has caused the devices to fail. In only seven cases worldwide, device failures have led to thermal damage to the device, with a remote potential to ignite material external to the device. No significant property damage or patient injury has been reported.

    ResMed has advised the U.S. Food and Drug Administration and other regulatory authorities of this action. ResMed is continuing to discuss this action with those authorities and will finalize its proposed course of action after those discussions are concluded.

    ResMed's S8 flow generators are distributed through medical equipment suppliers throughout the world. Affected products can be identified by the serial numbers on the bottom of each device. ResMed is working in close partnership with its distribution partners and the medical community to ensure that patients are fully aware of the replacement program and that patients who have an affected device will receive a replacement S8 flow generator.

    Patients will be contacted as soon as possible to arrange for a replacement device and are encouraged to visit http://www.resmed.com/en-us/s8program/s8program.html for more information. Patients in the U.S. and Canada may also contact the ResMed S8 Replacement Call Center at 888-899-8991. Contact information for patients in Latin America, Europe and Asia Pacific is available at www.resmed.com/s8program.

    Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's Med Watch Adverse Event Reporting Program either online, by regular mail or by fax.

    Online: www.fda.gov/medwatch/report.htm
    Regular mail: Use postage-paid FDA form 3500 available at:
    www.fda.gov/medwatch/getforms.htm. Mail to: MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
    Fax: 1-800-FDA-0 178

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    : FDA Alerts and Recalls...

    Bronson Advises Consumers To Check Refrigerators For Potentially Tainted Cheeses

    Contact:
    Dr. John Fruin
    (850) 245-5520

    FOR IMMEDIATE RELEASE -- Tallahassee, FL -- April 27, 2007 -- Florida Agriculture and Consumer Services Commissioner Charles H. Bronson is urging consumers to check their refrigerators for Ole Mexican Foods' Verole Queso Fresco Authentic Mexican Crumbling Cheese and Ole Fresco Authentic Mexican Crumbling Cheese. The two products may be contaminated with E. coli bacteria.

    The potential for this contamination was determined after random testing performed by the Florida Department of Agriculture and Consumer Services revealed the presence of E.coli bacteria in samples of both of the cheeses.

    "The discovery of this problem demonstrates the importance of an integrated pro-active food safety program, where products from stores and food processors are not only inspected but tested in our labs, as well," Bronson said.

    Department inspectors are working with Florida grocery chains to remove any of the potentially tainted cheese from those stores and are checking warehouses in Florida from which the products were distributed. Bronson said his agency has also notified the U.S. Food Drug Administration, which is responsible for the products in other states.

    The affected code for Verole Queso Fresco Authentic Mexican Crumbling Cheese Net Wt. 15 oz. is V7&8 052 47193 SELL BY: 05/31/07; the affected code for Ole Fresco Authentic Mexican Crumbling Cheese Net Wt. 12 oz. is V5&6 051 47193 SELL BY: 05/30/07. Consumers who have purchased these products are urged to return them to the place of purchase.

    No illnesses have been reported to date in connection with this problem.

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    : FDA Alerts and Recalls...

    FDA Requests Recall of All Shelhigh Medical Devices

    The U.S. Food and Drug Administration (FDA) today issued a formal written request to Shelhigh, Inc. to recall all of its medical devices remaining in the marketplace, including hospital inventories, because of sterility concerns.

    On April 17, 2007, U.S. Marshals, at FDA's request, seized all medical devices including components at Shelhigh's Union, N.J. facility after finding significant deficiencies in the company's manufacturing processes. During the seizure, Shelhigh was asked to perform a voluntary recall of its products, but the company declined.

    FDA recommends that doctors and hospitals consider using alternative products. Physicians and patients concerned about Shelhigh devices can visit www.fda.gov/cdrh/safety/041907-shelhigh.html and http://www.fda.gov/cdrh/medicaldevic...-shelhigh.html for more information, including a list of the company's products.

    "Since these are critical devices implanted into seriously-ill patients, ensuring their sterility is absolutely essential to prevent infection," said Daniel Schultz, M.D., director, FDA's Center for Devices and Radiological Health. "FDA will continue to provide up-to-date information to patients and physicians about this ongoing public health matter."

    The company's deficiencies, described in a complaint filed with the U.S. District Court of New Jersey, may compromise the safety and effectiveness of the devices. Shelhigh's own records indicate a number of sterility test failures and that its testing and retesting procedures were not properly performed.

    Shelhigh devices are used in infants, children and adults. The products include pediatric heart valves, tube-like devices for blood flow (conduits), surgical patches, dural patches to aid in tissue recovery after neurosurgery, annuloplasty rings to help repair heart valves, and arterial grafts.

    Adverse reactions or quality problems experienced with the use of these products may be reported to FDA's MedWatch Adverse Event Reporting program either online (www.fda.gov/medwatch/report.htm), fax (800-332-0178), or regular mail (use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787).

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    : FDA Alerts and Recalls...

    Galliker Dairy Issues a Product Recall on Half-Gallons of Healthy Chekd Calcium Enriched Fat Free Milk

    Contact:
    Galliker Dairy
    800-477-6455

    FOR IMMEDIATE RELEASE -- Johnstown, PA -- May 3, 2007 -- Galliker Dairy Company of Johnstown, Pennsylvania, is recalling half-gallon packages of Galliker's Healthy Chekd Calcium Enriched Fat Free Milk because they are over-fortified with Vitamin A. High levels of Vitamin A can be harmful to people with a Vitamin A sensitivity. Only products coded May 14, 2007 are affected. The product comes in a 64-ounce (One Half-Gallon), plastic package marked with the code date on the front of the package. No illnesses have been reported to date in connection with this problem.

    The recall was initiated after a chemical test indicated that over-fortification occurred. All of Galliker's processing documents indicate that the proper procedures were followed. Currently the company and the Pennsylvania Department of Agriculture are reviewing how vitamins are added to this product. Only this one product is involved. All distribution was contained within the state of Pennsylvania.

    Production of this product will continue while this incident is investigated. Products having any other code date are not affected.

    Retailers are asked to pull-from-sale all unsold Galliker's Healthy Chekd Calcium Enriched Fat Free Milk with the code date of May 14, 2007 and return them for full refund. Consumers with any questions may contact the company at 800-477-6455.

    This recall is being made with the knowledge of the US Food and Drug Administration and the Pennsylvania Department of Agriculture.

    The UPC for this product is 070474-001766. Thank you for your cooperation and we apologize for any inconvenience.

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