Wegmans Recalls Various Prepared Foods That Contain Hard-Cooked Eggs

Wegmans Food Markets, Inc. is recalling hard-cooked eggs, as well as prepared foods that contain hard-cooked eggs, sold between January 23 and February 1, 2012 because the eggs 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 high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.  

This recall only affects purchases made at Wegmans’ Rochester, Buffalo, Syracuse, Canandaigua, Newark, Geneva, Corning, Elmira, Geneseo, and  Hornell stores.  It came about as the result of a recent recall by Minnesota-based Michael Foods, Inc., which produces the cooked eggs at its Wakefield, Nebraska facility.

The following affected products sold in Wegmans prepared foods and deli departments are included in the recall:
Hard-Cooked Eggs (sold by the pound in prepared foods or as a choice on the Fresh Foods Bar)    

Eggs (special-order deli tray or 6-pack, 12 pack)
Cobb Salad (10 oz, 43 oz, and 6.5 lb)
Garden Salad (10 oz, 20 oz, 2 lb, and 5 lb)
Baby Spinach Salad (9 oz, 1.8 lb, and 3.9 lb)
Chef Salad (9 oz. and 18 oz.)
Egg Salad (sold by the pound in prepared foods)
Egg Salad Sub (Sub Shop)
Kosher Macaroni Salad (sold by the pound in kosher deli)
Kosher Pickled Eggs (sold by the pound in kosher deli)

There have been no confirmed reports of illness in connection with these products. Wegmans has placed automated phone calls to customers who purchased the products using their Shoppers Club card.

According to Michael Foods, the recall was initiated after lab testing revealed that some of the eggs within the recalled lot dates may have been contaminated with Listeria monocytogenes. A recall of three lot dates was announced on Thursday, January 26, but Wegmans had not received any of the three initial lot codes. As a precautionary measure, the recall was expanded on February 1 to include additional lot dates, one of which was received by Wegmans. Michael Foods reached the decision to expand this recall after a thorough investigation which indicated a specific repair project that took place in the packaging room as the likely source of the contamination. The company has taken a number of corrective steps to address the issue and prevent recurrence.

Because these are fresh products with a very short shelf life, it is likely they have already been consumed.  However, consumers who may still have the product in their homes should discard it and return to the service desk for a refund.  If consumers have additional questions or concerns, please contact Wegmans at (800) 934-6267   (800) 934-6267, and ask for consumer affairs, M – F, 8 am to 5 pm EST.

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.

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.

Alfalfa Sprouts Recalled Because of Possible Health Risk

Jonathans Sprouts of Rochester, MA is upgrading its recall of conventional alfalfa sprout products with a specific sell-by date to include all of its alfalfa products, conventional and organic, with all sell-by dates, as a precaution, 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 Salmonellacan result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

Six products are involved:

• Jonathan’s 4oz Alfalfa Sprouts – all sell-by dates
• Jonathan’s 4oz Organic Alfalfa Sprouts – all sell-by dates
• Jonathan’s 4oz Alfalfa with Radish Sprouts – all sell-by dates
• Jonathan’s 4oz Organic Alfalfa with Radish Sprouts – all sell-by dates
• Jonathan’s 4oz Gourmet Sprouts – all sell-by dates
• Jonathan’s 4oz Alfalfa with Dill Sprouts – all sell-by dates
• Jonathan’s 8oz Alfalfa Sprouts – all sell-by dates
• Jonathan’s Organic Sprout Salad – all sell by dates

The product is sold in plastic containers, approximately 4 inches cube. See attached photographs.

They are sold at the following stores:

A&P, Grand Union, Stop & Shop, Shaws, Hannaford, Donnelans, Foodmaster, Truccis, Roche Brothers

The product being recalled was identified through routine sampling as part of the USDA Microbiological Data Program.

Consumers who have purchased Jonathans Sprouts products containing alfalfa sprouts are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 508-763-2577 .

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

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

Recall of Tearing INOMAX DS Drug Delivery Systems

Ikaria Holdings
6 State Route 173
Clinton, New Jersey 08809

INOMAXDS Drug Delivery System, model 10003

This product delivers INOMAX (nitric oxide) to help patients breathe. A component within the pressure switch, which monitors when the drug supply should be replaced, may tear. Risks to the patient may include interruption of drug flow due to an empty cylinder, and/or the time taken to switch to a replacement system. An interruption or delay in the administration of INOMAX therapy may cause:

• Worsening of low blood oxygen level (hypoxemia)
• Low blood pressure (hypotension) and/or
• Increase in blood pressure in the pulmonary arteries (pulmonary hypertension)
• Death

On July 21, 2010, the company sent their customers a recall notice which described the steps intended to reduce the potential risks associated with a system failure. This notice was also posted on the INOMAX webpage www.inomax.com or www.ikaria.com. The notice described the issue, how to recognize the problem, what to do, and described the long-term fix of replacing all INOMAX DS drug-delivery systems.

The company’s August 9, 2010 press release contained the following recommendations:

“If a leak is suspected, clinicians should: 1) not interrupt the delivery of INOMAX; 2) verify an adequate amount of INOMAX remains in the cylinder; 3) switch to the manual back-up system using the INOblender® by connecting the INOMAX Inlet Hose of the INOblender directly to the INOMAX regulator, and follow the standard procedure for use of the INOblender as the primary back-up method for manual ventilation, and; 4) contact Ikaria Customer Care at 1-877-KNOW-INO (1-877-566-9466) for assistance.”

“Although the risk of INOMAX exposure to pregnant women is unknown, it is advised that healthcare professionals who may be pregnant avoid the immediate area in which a leak is suspected.”

Ikaria has already begun the replacement process of all INOMAX DS drug-delivery systems with remediated INOMAX DS systems. This recall does not apply to the INOvent® drug-delivery system.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

Customers with questions may contact Ikaria Customer Care at 1-877-KNOW-INO (1-822-566-9466).

Original Release

Recall of False-Negative MRSA Tests

Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System

This test is used to detect methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) DNA directly from patient positive blood culture determined to be Gram Positive Cocci in Clusters (GPCC) or Gram Positive Cocci in singles (GPC) by Gram stain.

The firm received increasing numbers of complaints for false negative MRSA results when compared to MRSA positive results received from culture methods. All Cepheid MRSA/SA Blood Culture Assay products have a potential of generating infrequent rates of false negative MRSA results, which could result in incorrect treatment or delay of care for patients with MRSA infection.

On July 1, 2010, the company issued a press release and sent its customers a revised Corrective Action Notice letter instructing them not to report the MRSA negative result when a MRSA negative/SA positive result is generated on the Cepheid MRSA/SA Blood Culture Assay.  Instead, customers were instructed to conduct further antimicrobial susceptibility testing to determine the MRSA result. The MRSA positive/SA positive results generated on the Cepheid MRSA/SA Blood Culture Assay can still be reported.  The new instructions will be incorporated in future product labeling.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Healthcare professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

FDA Release