Strangulation & Death – King International Recalls the Shoulderflex Massager

In cooperation with the Food and Drug Administration (FDA), King International LLC Is initiating a recall of the Shoulderflex massager due to a report of a strangulation and death. Consumers, retailers and catalog sellers are being advised to immediately stop using Shoulderflex massagers, and to safely dispose of them in the trash.

This announcement relates to all of the approximately 12,000 Shouderflex massagers which were sold between 2003 and 2011. The devices were sold at various stores (including Relax the Back), in catalogs (including Lifestyle Fascination), and online retailers (including Amazon) in the United States.

King International advises that the device components be disposed of separately so that the massager cannot be reassembled and used. The most effective way to do that is to dispose of the power supply separate from the massager unit, and to remove the massage fingers and dispose of them separately.

This is a voluntary recall program conducted by King International as part of its commitment to safety. There has been a report of a strangulation and death. There was a warning never to wear a necklace to avoid entanglement. King International shares FDA’s desire to take prompt action to reduce the risk of injury. Accordingly, King International asks customers to immediately stop using Shoulderflex massagers and to safely dispose of them in the trash, and for retailers and catalog sellers to take similar action.

Additional information about this recall campaign can be obtained from King International LLC at (503) 524-7046 (www.shoulderflex.com) or by writing to King International at PO Box 2384, Beaverton, OR 97075.

Taylor Farms Pacific, Inc. Recalls Grape Tomatoes Due to Salmonella Risk

Contact:
Consumer:
(209) 835-6300
Media:
Gurjit Shergill, Vice President of National Quality Systems
(209) 835-6300 ext. 186

FOR IMMEDIATE RELEASE – May 2, 2011 – Taylor Farms Pacific, Inc. of Tracy, CA has been notified by grower Six L’s that a specific lot of grape tomatoes supplied to Taylor Farms Pacific may be contaminated with Salmonella. This product has been recalled by Six L’s.

This lot of grape tomatoes was used in the following products made by Taylor Farms Pacific for Albertsons, Raley’s, Safeway, Savemart, Sam’s Club, & Walmart and is being voluntarily recalled as a precautionary measure. No illnesses have been reported.

Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy people may experience fever, nausea, vomiting, diarrhea (which may be bloody), and abdominal pain. In rare cases the organism can get into the bloodstream and cause more serious complications. For more information visit the Centers for Disease Control and Prevention’s website at www.cdc.gov.

Porky Products Inc. Recalls Salted Smoked Split Herring Infected With Botulism

Contact:

Trading Division 13949 Ventura Blvd. Suite 203
Sherman Oaks, CA 91423
(818)325-2575
FAX (818) 509-9572

CORPORATE HEADQUARTERS
Distribution Division
400 Port Carteret Drive
Carteret, NJ, 07008
(732)541-0200
FAX (732) 969-6079

Monday to Friday; 9AM to 5PM
732-359-9226-Sal DiMauro
732-359-9219-Dominic Gold
732-359-9151-Miriam Lora
732-359-9170-Ingrid Almanzar

FOR IMMEDIATE RELEASE – May 2, 2011 – Porky Products of Carteret, NJ is recalling Salted Smoked Split Herring (bloaters) because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to consume the product even if it does not look or smell spoiled.

Botulism, a potentially fatal form of food poisoning, can cause the following symptoms: general weakness, dizziness, double-vision and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms. People experiencing these problems should seek immediate attention.

The Salted Smoked Split Herring (Bloaters), were distributed in New Jersey, New York, Connecticut, North Carolina, Maryland and Pennsylvania through Supermarkets.

The product is in 18lb boxes with a lot # of 274 10 which were distributed to the market from April 14-28, 2011.

The product is imported from Canada and is uneviscerated. It may have the potential to cause botulism. However, note that no illnesses have been reported to date.

Customers who have purchased and who still have this product in stock are urged to return it to Porky Products Inc. for a full refund. Customers who have questions may contact their Porky Sales Rep.

Satur Farms, LLC Recalls Cilantro Because Of Possible Health Risk

Contact:
631-734-4219

FOR IMMEDIATE RELEASE – April 29, 2011 – Satur Farms of Cutchogue, NY is recalling 88.5 pounds of Satur Farms Cilantro, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The Satur Farms Cilantro was distributed in New York City and Long Island, New York.

The Cilantro in question was distributed to food service customers in 1/2 LB. and 1 LB. bulk bags which contained a small white stick-on label with four digit number lot number 6361.

No illnesses have been reported to date.

The presence of Salmonella was detected by the FDA in a routine test. Satur Farms has conducted independent tests of our cilantro and cilantro seed through Alliant Food Safety Labs, and all findings have come up negative for Salmonella, however the farm is voluntarily recalling this lot of cilantro as a precautionary measure. Satur Farms has voluntarily ceased the distribution of cilantro.

None of the recalled cilantro was shipped to retail markets. Food service customers who have purchased Satur Farms Cilantro from the lot in question are urged to return it to Satur Farms. Customers with any questions may contact the company at 631-734-4219, Monday through Friday, 8 am – 4 pm EDT.

Defibtech Announces a Voluntary Recall of DDU-100 series AEDs

Contact:

Consumer:

877-453-4507

techsupport@defibtech.com

Media:

Ray Valek

708-352-8695

ray@defibtech.com

FOR IMMEDIATE RELEASE – April 29, 2011 – Defibtech, LLC is initiating a worldwide voluntary recall of certain DDU-100 series semi-automatic external defibrillators (AEDs) sold under the Lifeline AED and ReviveR AED brand names, including 65,885 AEDs distributed in the United States. This recall affects only DDU-100 Series AEDs shipped with 2.004 software or earlier. This corrective action addresses two possible conditions, which in rare cases may cause an affected AED to cancel shock during the charging process and not provide therapy which may result in failure to resuscitate the patient. Both conditions are not detectable by the periodic self test.

Condition 1: In rare instances, the AED may cancel charge in preparation for a shock. Based on field data, the odds of an affected AED having this happen are less than a 1 in 400,000 chance per month for any given AED.

A subset of AEDs (less than 11%) that are affected by Condition 1 are also affected by Condition 2: In rare instances, the AED may cancel charge in preparation for a shock in very high humidity conditions. The only reported cases were in environments of greater than 95% relative humidity or condensing conditions. Based on field data, the odds of an affected AED having this happen are less than a 1 in 250,000 chance per month for any given affected AED.

Defibtech will provide customers with a free software upgrade to address these issues. The correction to the AED will be able to be performed at the location where the AED is deployed.

Because both of these conditions occur very rarely, it is recommended that customers keep their AEDs in service until they have performed the software upgrade. Full instructions and recommendations are being mailed to affected customers. This customer notification, as well as instructions on determining whether an AED is affected, can also be found on the www.defibtech.com/fa11web page. For additional information regarding this recall, please refer to the above referenced web page, contact your distributor, or contact Defibtech at techsupport@defibtech.com, 1-877-453-4507 or 1-203-453-4507.

The AEDs affected by this recall have been distributed globally to fire departments, EMS, health clubs, schools, and other organizations. The Food and Drug Administration (FDA) has determined that this action is a Class I recall. Any adverse reactions experienced with the use of this product and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800- FDA-1088, or on the MedWatch website at www.fda.gov/medwatch.

Prostate Drug “U-Prosta” Recalled Due to Unapproved Ingredient

Contact:
Jamie Sun
626-576-1299

FOR IMMEDIATE RELEASE – March 22, 2011 – USA Far Ocean Group Inc., 1609 W. Valley Blvd., #338, Alhambra, CA 91803, announced today that it is conducting a voluntary nationwide recall of the Company’s supplement product sold under the name “U-Prosta Natural support for prostate health”. The Company has been informed by representatives of the U.S. Food and Drug Administration (FDA) that lab analysis by FDA of U-Prosta samples found the product contains terazosin, the active ingredient of an FDA-approved drug used to treat Benign Prostatic Hyperplasia (enlarged prostate), making U-Prosta an unapproved drug.

The most likely adverse health consequences that could occur with the use of this product would be hypotension, dizziness, or syncope. Patients who are currently being treated with prescription medications for high blood pressure or enlarged prostate would be at increased risk of these events. In these patients, the hypotensive events may be more severe. No illnesses have been reported to the company to date in connection with this product.

The product has been distributed nationwide via retail stores, internet sales and mail order. All of the following U-Prosta products, which are packaged in white plastic bottles & 1 capsule blister pack, are involved in this voluntary recall:

Product	Package Size	UPC Codes
U-Prosta Dietary Supplement	30 capsules	689076499255
U-Prosta Dietary Supplement	60 capsules	88858100030
U-Prosta Dietary Supplement	1 capsule	No UPC Code

Consumers in possession of the affected product are urged to stop using it immediately and return it to the place of purchase for a full refund. Consumers with questions may contact USA Far Ocean Group, Inc. Special Recall number at 626-576-1299, Monday through Sunday, between 9 a.m. and 5 p.m. Pacific Standard Time.    Consumers should contact their physician if they have experienced any problem that may be related to taking this product. Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by:

• Online: www.fda.gov/medwatch/report.htm
• Fax: 1-800-FDA-0178
• Regular Mail: use postage-paid FDA form 3500 available at:

www.fda.gov/MedWatch/getforms.htm
Mail to: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

A Pain for Tylenol – Products Recalled

McNeil Consumer Healthcare Initiates Voluntary Recall Of Certain Over-The-Counter (OTC) Products

In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. is voluntarily recalling, at the wholesale level, certain lots of TYLENOL® 8 Hour, TYLENOL® Arthritis Pain, and TYLENOL® upper respiratory products, and certain lots of BENADRYL®, SUDAFED PE®, and SINUTAB® products distributed in the United States, the Caribbean, and Brazil. These products were manufactured at the McNeil plant in Fort Washington, PA prior to April 2010, when production at the facility was suspended. The company is initiating the recall as a precautionary measure after an extensive review of past production records found instances where equipment cleaning procedures were insufficient or that cleaning was not adequately documented. It is very unlikely that this impacted the quality of these products.

McNeil Consumer Healthcare is also initiating a voluntary recall of certain product lots of ROLAIDS® Multi-Symptom Berry Tablets distributed in the United States, in order to update the labeling. The company initiated the recall after determining that the product labeling does not include the language “Does not meet USP” as required by regulation.

Both of these recalls are being initiated at the wholesale level. No action is required by consumers or healthcare providers and consumers can continue to use the product. These actions are not being undertaken on the basis of adverse events.

McNeil identified the inadequacies as part of a thorough, proactive product quality and process assessment of all McNeil produced products. As previously announced, McNeil has been implementing a Comprehensive Action Plan at its U.S. manufacturing facilities to improve the quality systems at those sites. This product assessment is a key milestone in the implementation of that plan, and the actions being undertaken as a result of the assessment are part of McNeil’s ongoing commitment to ensure that all its products meet the high quality standards that consumers expect.

Consumers can access full product details and other information about the recall on the www.mcneilproductrecall.com⁹ website or by calling our Consumer Care Center at 1-888-222-6036 (available Monday-Friday from 8 a.m. – 8 p.m. ET and Saturday – Sunday, 9 a.m. – 5 p.m. Eastern Time).

Any adverse reactions may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Online: http://www.fda.gov/MedWatch/report.htm

Tiny Greens Organic Farm Food Recalls Alfalfa Sprouts Due To Salmonella

Contact:
Office
(217) 328-9367

FOR IMMEDIATE RELEASE – December 29, 2010 – Tiny Greens of Urbana, Ill., is recalling all Alfalfa Sprouts and Spicy Sprouts from November 1st thru December 21st because they have the potential to be contaminated with Salmonella.  Product was distributed thru various distributors in Illinois, Indiana, and Missouri and could have ended up in restaurants and supermarkets near those areas.

Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

We have decided to voluntarily recall our 4 oz. Spicy Sprouts and our 4 oz., 1 lb., 2 lb., & 5 lb. Alfalfa Sprouts (all package sizes) with lot codes 348, 350, or 354, or having a “sell by” date of 12/29/10, 12/31/10 or 1/04/11. As well, we would like to recall any product containing alfalfa sprouts with our lot number 305 thru 348 or ”sell by” dates from 12/16/10 thru 12/29/10.

The mutual goal of both the FDA and Tiny Greens is to pinpoint the source of the contamination and stop the spread of Salmonella.  To this end, Tiny Greens has decided that it is better to risk its reputation than to risk getting anyone sick. There is only a statistical association at this point to Tiny Greens alfalfa sprouts and The FDA and Tiny Greens are continuing to work closely together, sharing all data with each other to find the source of the problem.

There have been 51 confirmed cases of Salmonella I, 4, [5] I, 12, i-, in Illinois and around that same number in 15 other states. This is a common strain for Salmonella contamination and the cases in distant states are probably not linked to the ones in Illinois.

The illnesses were reported after individuals reported eating alfalfa sprouts at Jimmy John’s restaurants in Illinois. The FDA and Tiny Greens and the Illinois Department of Public Health continue their investigation as to what caused the problem.

If consumers have any of the product they can return it for full credit or destroy it by placing it in a plastic bag or other closed container before discarding it. Consumers can call 1-800-352-8526 for more information from 9am till 5pm.

 

Headache for Rolaids(R)?

McNeil Consumer Healthcare Announces Voluntary Recall Of All Lots Of Rolaids® Extra Strength Softchews, Roldaids® Extra Strength Plus Gas Softchews, And Roldaids® Multi-Symptom Plus Anti-Gas Softchews Sold In The United States

 Contact:
McNeil Consumer Healthcare
http://www.rolaids.com⁹
1-888-222-6036  
McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. is voluntarily recalling all lots of ROLAIDS® Extra Strength Softchews, ROLAIDS® Extra Strength plus Gas Softchews, and ROLAIDS® Multi-Symptom plus Anti-Gas Softchews (full product details below) distributed in the United States. McNeil is taking this action following some consumer reports of foreign materials in the product, including metal and wood particles. The company’s investigation has determined that the materials were potentially introduced into the product during the manufacturing process at a third party manufacturer. While the risk of serious adverse health consequences is remote, McNeil Consumer Healthcare advises consumers who have purchased these recalled products to discontinue use.

While our investigation is ongoing we have suspended production of ROLAIDS® Extra Strength Softchews, ROLAIDS® Extra Strength plus Gas Softchews, and ROLAIDS® Multi-Symptom plus Anti-Gas Softchews and will not restart production until corrective actions have been implemented.

Consumers who purchased product included in this recall should contact McNeil Consumer Healthcare, either at http://www.rolaids.com¹⁰
or by calling 1-888-222-6036 begin_of_the_skype_highlighting              1-888-222-6036      end_of_the_skype_highlighting (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time) for instructions about receiving a refund. Consumers who have medical concerns or questions should contact their healthcare provider.

Any adverse reactions may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
 Online: http://www.fda.gov/MedWatch/report.htm¹¹
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm¹².
Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Product Information: Product NDC numbers can be located on the label of the package above the brand name. Lot Numbers and Expiration Dates can be found on back, side or bottom label of the package. If you cannot find the NDC number, lot number, or expiration date on the label, Click here¹³ for examples or call the Consumer Care Center at 1-888-222-6036
CLICK HERE¹⁴ TO FIND OUT IF YOUR ROLAIDS® SOFTCHEWS PRODUCT IS PART OF THE DECEMBER 9, 2010 RECALL.

FULL RECALLED PRODUCT LIST:

Product Name	Lot Number	UPC
ROLAIDS® Extra Strength Softchews, Wild Cherry
ROLAIDS® Extra Strength Softchews, Wild Cherry, 6 count	9015A, 9016A, 9019A, 9140A, 9138A,9210A, 9211A,9315A, 9316A	312547655200
ROLAIDS® Extra Strength Softchews, Wild Cherry, 18 count (3 packs of 6 count)	9075A, 9076A, 9103A, 9098A, 9104A, 9239A, 9240A, 9348A	312547655255
ROLAIDS® Extra Strength Softchews, Wild Cherry, 42 count (7 packs of 6 count)	9065A, 9068A, 9069A, 9131A, 9132A, 9208A, 9209A, 9286A, 9287A	312547655316
ROLAIDS® Extra Strength Softchews, Cherry
ROLAIDS® Extra Strength Softchews, Cherry, 6 count	0109A, 0114A, 0115A, 0134A, 0135A, 0165A, 0238B, 0239A, 0239C, 0262A, 0264A	312547655200
ROLAIDS® Extra Strength Softchews, Cherry, 18 count bag	9349AG2, 9350AG1, 0015AG2, 0015AG3, 0050AG1, 0051AG1, 0053BG2, 0106BG2, 0107AG1, 0108AG1, 0108BG3, 0108CG1, 0129BG1, 0133AG1, 0133AG2, 0165BG2, 0191BG1, 0191CG1, 0191DG1, 0213AG2, 0238AG1, 0238AG2, 0246AG1	300450649188
ROLAIDS® Extra Strength Softchews, Cherry, 36 count bag	9350AG2, 0012AG1, 0013AG1, 0014AG1, 0015AG1, 0015AG4, 0050AG2, 0053AG2, 0053BG1, 0053BG2, 0094AG1, 0106AG1, 0106BG1, 0108AG2, 0108BG2, 0191AG1, 0139BG2, 0165BG1, 0191BG1, 0207AG1, 0207AG2, 0213AG1, 0227AG1, 0246AG2, 0247AG1, 0265AG1, 0266AG1	300450649362
ROLAIDS® Extra Strength plus Gas Softchews, Tropical Fruit
ROLAIDS® Extra Strength plus Gas Softchews, Tropical Fruit, 6 count	9005A, 9006A	312547065733
ROLAIDS® Extra Strength plus Gas Softchews, Tropical Fruit, 12 count (2 packs of 6 count)	9022A, 9027A, 9118A, 9119A, 9195A, 9196A	312547065757
ROLAIDS® Extra Strength plus Gas Softchews, Tropical Fruit, 36 count (6 packs of 6 count)	9166A, 9167A	312547065771
ROLAIDS® Multi-Symptom plus Anti-Gas Softchews, Tropical Fruit
ROLAIDS® Multi-Symptom plus Anti-Gas Softchews, Tropical Fruit, 6 count	0017B, 0095A, 0096B, 0259A, 0260A	300450657060
ROLAIDS® Multi-Symptom plus Anti-Gas Softchews, Tropical Fruit, 12 count bag	9351BG1, 9352AG1, 0016AG1, 0059AG2, 0059BG1, 0059BG2, 0060AG2, 0167AG2, 0167AG3, 0203AG1, 0204AG1	300450657121
ROLAIDS® Multi-Symptom plus Anti-Gas Softchews, Tropical Fruit, 24 count bag	9352AG2, 9352BG2, 0016AG2, 0017AG1, 0057BG1, 0058AG1, 0059AG1, 0059BG3, 0060AG1, 0129AG1, 0132AG1, 0167AG1, 0167BG1, 0204AG2, 0205AG1, 0230AG1, 0231AG1	300450657244

CLICK HERE¹⁵ TO FIND OUT IF YOUR ROLAIDS® SOFTCHEWS PRODUCT IS PART OF THE DECEMBER 9, 2010 RECALL.

CLICK HERE¹⁶ FOR A REFUND OF YOUR PRODUCT

CLICK HERE¹⁷ TO SEE FREQUENTLY ASKED QUESTIONS

CLICK HERE¹⁸ FOR INFORMATION ABOUT RECALLS OF ROLAIDS® AND OTHER PRODUCTS

Del Bueno Recalls Cheese Because Of Possible Health Risk

 

Contact:
Del Bueno
Del Bueno of Grandview, WA is recalling all size packages of Queso Fresco Fresh Cheese, Queso Panela Fresh Cheese, Requeson Mexican Style Ricotta Cheese, and Queso Enchilado Dry Cheese because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.  Although healthy individuals may suffer only short-term symptoms such as fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

Fresh Mexican Cheese

Del Bueno distributed the cheese to retail markets in Washington and Oregon and to the flea market in Pasco, WA. 

The following products are being recalled:

• Queso Fresco Fresh Cheese, UPC 75318225028 for 16 oz. package, UPC 753182814063 for 3 lbs. package, date code up to and including Feb 10 2011.
• Queso Panela Fresh Cheese, UPC 753182814056, date code up to and including Feb 10 2011.
• Requeson Mexican Style Ricotta Cheese, UPC 753182814070, date code up to and including Jan 10 2011
• Queso Enchilado Dry Cheese, no UPC date code up to and including Mar 15 2011.

The date code is stamped on the back of the packages.  This date code is to signify the expiration date.  The cheese is packaged either in 1 lb. or 3 lbs. plastic vacuum bags. 

No illnesses have been reported to date.

The recall is the result of the environmental samples and finished product samples by Food and Drug Administration (FDA) and the result of the finished product samples by Washington State Department of Agriculture (WSDA).  The test results revealed that the cheeses are contaminated with Listeria monocytogenes.

Del Bueno has notified their customers and has pulled the products from retail stores.  The firm is working with FDA to conduct the recall.

Consumers who have purchased Del Bueno brand cheeses are urged to return them to the place of purchase for a full refund.  Consumers with questions may contact Del Bueno at 425-503-3823