Category Archives: Information

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.

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:

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 .

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.disclaimer icon 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

Salmonella in Alfalfa Sprouts

Contact:
Jessica Chittenden Ziehm
518-457-3136

New York State Agriculture Commissioner Patrick Hooker today alerted consumers that Snow White Food Products Inc., located in 621 Bergen Street in Brooklyn, New York, is recalling certain packages of “Alfalfa Sprouts” due to the presence of Salmonella.

The recalled “Alfalfa Sprouts” is packaged in a 3.5 ounce plastic clamshell container which is uncoded. It has a UPC code of 0-46421-11236-6. The product was distributed in New York State.

Salmonella is an organism that 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 that 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, endocarditis and arthritis. No illnesses have been reported to date to this agency in connection with the recalled product.

The contamination was discovered after a sample analyzed by the New York State Food Laboratory revealed the presence of Salmonella in some 3.5 ounce containers of Snow White Food Products “Alfalfa Sprouts.” Production and sale of the product has been suspended.

Consumers who have purchased 3.5 ounce containers of Snow White Food Products “Alfalfa Sprouts” are urged to return them to the place of purchase or discard the product. Consumers with questions may contact the company directly at 718-230-5625.

Original Release