Joseph Epstein Food Enterprises, Inc. Recalls Gluten-Free Turkey Meatball Products Due to Misbranding

Class II Recall 134-2015
Health Risk: Low Oct 30, 2015
Congressional and Public Affairs
Kristen Felicione
(202) 720-9113

WASHINGTON, Oct. 30, 2015 – Joseph Epstein Food Enterprises, Inc., an East Rutherford, N.J. establishment, is recalling approximately 190 pounds of turkey meatball products due to misbranding, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The label declares the product as “gluten-free,” a false negative claim.

The Mama Mancini’s gluten-free turkey meatball items were produced on Oct. 19, 2015. The following products are subject to recall: [View Labels]

22-oz. cartons of “Mama Mancini’s Slow Cooked Italian Style Sauce and Turkey Meatballs – Gluten Free.”
The products subject to recall bear establishment number “P-21734” inside the USDA mark of inspection, product code 4740 and expiration date “Use by 12/10/15.” These items were shipped to retail locations in New Jersey.

The problem was discovered during the establishment’s third party laboratory testing; the product was found to contain an excess of the maximum allowable 20 ppm of gluten. The establishment notified FSIS of the problem.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.

Consumers with questions about the recall can contact Mr. Matt Brown, President, at (917) 705-7514. Media with questions about the recall can contact Mr. Carl Wolf at (973) 985-0280.

Pelmen Foods Recalls Beef, Chicken and Pork Products Produced Without Benefit of Import Inspection

Class I Recall 133-2015
Health Risk: High Oct 30, 2015
Congressional and Public Affairs
Alexandra Tarrant
(202) 720-9113

WASHINGTON, Oct. 30, 2015 – Pelmen Foods, an Ontario, Canada, establishment, is recalling approximately 332 pounds of beef, chicken and pork dumpling products that were not presented at the U.S. point of entry for inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. Without the benefit of full inspection, a possibility of adverse health consequences exists.

The dumpling products were imported on Oct. 8, 2015. The following products, sold between Oct. 8, 2015 and Oct. 30, 2015, are subject to recall: [View Labels (PDF Only)]

12.4 lb. cases containing 12 bags of “Pelmen Foods PELMENI Siberian Recipe (Pork & Beef)” with “EXP Oct 02’ 16” and Lot 5275 on the bags
12.4 lb. cases containing 12 bags of “Pelmen Foods PELMENI Chicken” with “EXP Oct 02’ 16” and Lot 5275 on the bags
The products subject to recall bear establishment number “721” inside Canada’s mark of inspection. These items were shipped to distributors in Illinois and Wisconsin.

The problem was discovered during routine FSIS surveillance activities of imported products.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.

Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.

Consumers and media with questions about the recall can contact Svetlana Minos, Quality Assurance and HACCP Coordinator, at (416) 661-9600 Ext 205.

Stop & Shop Alerts Customers To Voluntary Recall Of Nature’s Promise Organic Edamame

Consumers: Stop & Shop Customer Service 1-800-767-7772

Purchase, NY & Quincy, MA – The Stop & Shop Supermarket Company LLC announced it removed from sale Nature’s Promise Organic Edamame products because they contain soy, which is not listed on the ingredient label. These products are safe to consume for individuals who do not suffer from a soy allergy.
The following products are included in this recall:

Nature’s Promise Organic Shelled Edamame, 16 oz., UPC 68826712764
Nature’s Promise Organic Edamame in Pod, 16 oz., UPC 68826702124
Stop & Shop has received no reports of illnesses to date. People who have an allergy or severe sensitivity to soy may run the risk of serious or life-threatening allergic reaction if they consume these products. Symptoms of food allergies typically appear from within a few minutes to two hours after a person has eaten the food to which he or she is allergic. Allergic reactions can include: hives; flushed skin or rash; tingling or itchy sensation in the mouth; face, tongue, or lip swelling; vomiting and/or diarrhea; abdominal cramps; coughing or wheezing; dizziness and/or lightheadedness; swelling of the throat and vocal cords; difficulty breathing; loss of consciousness.
Customers who have purchased these products should discard any unused portions and bring their purchase receipt to Stop & Shop for a full refund.

Consumers looking for additional information on the recall may call Stop & Shop Customer Service at 1-800-767-7772 for more information. Customers can also visit the Stop & Shop website at stopandshop.com

The Stop & Shop Supermarket Company LLC employs over 59,000 associates and operates 395 stores throughout Massachusetts, Connecticut, Rhode Island, New York and New Jersey. The company helps support local communities fight hunger, combat childhood cancer and promote general health and wellness – with emphasis on children’s educational and support programs. In its commitment to be a sustainable company, Stop & Shop is a member of the U.S. Green Building Council and EPA’s Smart Way program and has been recognized by the EPA for the superior energy management of its stores. Stop & Shop is an Ahold company. To learn more about Stop & Shop, visit www.stopandshop.com or www.facebook.com/stopandshop.

Farmer Creek is Issuing a Voluntary Recall on Canned Albacore Tuna Products because of a Possible Health Risk

Consumers: porterrockproducts@gmail.com or  503-812-3793

Farmer Creek of Cloverdale, OR is voluntarily recalling canned albacore tuna with the Farmer Creek brand label with any codes starting with “OC” because it has the potential to be contaminated with Clostridium botulinum, a bacterium that can cause life-threatening illness or death. Consumers are warned not to use 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 medical attention.

There have been no reported cases of illness to date.

All products were sold to consumers from our farm stand and farmers markets in Oregon. The last date of distribution of recalled products was September 2015. Affected production codes include any codes starting with “OC”. The code can be found either on the bottom or on top of the can. Recalled product is packaged in metal cans with net weight of 6oz.

This voluntary recall was initiated after we were notified that our products were possibly under-processed. The problem was discovered during an inspection at Skipanon Brand Seafoods LLC by the US Food and Drug Administration (FDA).

Consumers are advised to destroy recalled product.

If you have any questions, please contact Farmer Creek by email to porterrockproducts@gmail.com

Northstar Produce Inc. Recalls Granny Smith Size 175 Apples Because of Possible Health Risk

Consumers: Mike Abernathy 763-286-0110

Northstar Produce Inc.ofSt. Louis Park, MNthe presence of Listeria monocytogenes, Salmonella, and / or Enterohemorrhagic E. coli. is recalling 33 cases of Granny Smith Size 175ct apples, because a test performed on a sample of the apples indicated the presence of Listeria monocytogenes, Salmonella, and / or Enterohemorrhagic E. coli.
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.

Listeria monocytogenes, is 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.

Enterohemorrhagic E. coli is a bacteria that causes a diarrheal illness often with bloody stools. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called Hemolytic Uremic Syndrome (HUS). HUS is most likely to occur in young children and the elderly. The condition can lead to serious kidney damage and even death.

The Granny Smith Size 175ct apples were sold at Mike’s Discount Foods, 230 Osborn Ave., Fridley, MN and Mikes’s Discount Foods, 516 East River Road, Anoka, MN

The apples were sold in tray packs between October 1, 2015 and October 19, 2015

No illnesses have been reported to date.

Consumers who purchased these apples should directly contact Mike Abernathy at 763-286-0110.

Kar’s Nuts Recalling Certain Packages of Sweet ‘N Salty Mix

Consumers: Molly Titcombe
 mtitcombe@karsnuts.com or 800-527-6887

Kar’s Nuts, Inc. announces it has recalled a limited number of packages of their Sweet n Salty Mix products with best by dates between August 25, 2016 and September 2, 2016.
The recall is being initiated due to consumer reports of hard, clear foreign material (approximately one half the size of a sunflower kernel) being found in several packages. There are no reports of injury.

All recalled product is being removed from store shelves.

Consumers who have purchased the product with the best by dates in question can return it to its place of purchase for a full refund. Consumers with any questions may contact the company at 800-527-6887.

The list of specific items and their UPC codes will appear on the company’s website at karsnuts.com and also on the FDA website.

We value and appreciate the many consumers who purchase our products on a daily basis and consider us a favorite. We are committed to maintaining your trust and doing whatever it takes to ensure that our snacks are safe and enjoyable.

Hormel Foods Sales LLC Voluntarily Recalls a Limited Number of Jars of Skippy Reduced Fat Creamy Peanut Butter Spread Due to Possible Metal Pieces

Consumers: Hormel Foods Customer Relations: 1-866-475-4779

Hormel Foods Sales LLC is voluntarily recalling 153 cases, or 1,871 total pounds, of a single code date of SKIPPY® Reduced Fat Creamy Peanut Butter Spread, due to the possibility that some jars may contain small pieces of metal shavings which were discovered on an in-line magnet check during routine cleaning. Foodborne objects that are greater than 7mm in length may cause injury such as severe choking with airway obstruction, gastrointestinal peroration or secondary infection. The recalled product is limited to 16.3 ounce jars with a “Best If Used By” date of DEC1416LR1 with a package UPC code of 37600-10500. The code date is located on top of the lid. A photo of the product and “Best If Used By” date appears below. Recalled product was sent to distribution centers for Publix, Target and Walmart located in Georgia, Virginia, Alabama, North Carolina, South Carolina, Delaware and Arkansas.

The company is issuing the recall to ensure that consumers are made aware of the potential hazard. No reports have been received to date of any consumer injuries or complaints.

No other sizes, varieties or other packaging configurations of SKIPPY® brand peanut butter or peanut spreads are included in this recall.

If a consumer has this product, they should return it to the store where purchased for an exchange or call Hormel Foods Customer Relations at 1-866-475-4779, Monday-Friday, 8 a.m. – 4 p.m. Central Time, excluding holidays.

This recall is being initiated out of an abundance of caution and with the knowledge of the US Food and Drug Administration.

Quest Medical, Inc. Issues Recall of MPS® Delivery Set

Consumers: custserv@questmedical.com
 1-800-627-0226

On October 28, 2015, Quest Medical, Inc. initiated a nationwide recall of Myocardial Protection System (MPS) Delivery Sets, Models 5001102, 5001102-AS, and 7001102 of specified lots. The product(s) have been found to intermittently exhibit a seal failure during use, which potentially could result in patient blood loss.

There are no other recalls related to this product.

Consumers who have the applicable lots of the MPS Delivery Set(s) should cease use of the affected lots and contact Quest Medical, Inc. to return the product and request replacement. Additionally, consignees are being notified via written correspondence.

Recalled Product(s) were manufactured from May 2015 to September 2015 and distributed from June 2015 to September 2015.

The following models/UDI/ID numbers are subject to the recall:

MPS® Delivery Sets – Recall
Device Name MPS Delivery Set w/arrest agent and additive cassettes, heat exchanger & 10 ft. delivery tubing MPS Delivery Set with 6 ft. delivery tubing MPS Low Volume Delivery Set
Device Model 5001102 5001102-AS 7001102
UDI 00634624501126 00634624521124 00634624701120
Affected Lots 0491795E04, 0492175E04, 0492185E06, 0492195E06, 0492615E06, 0492625E08 0492635E08, 0489905Y04, 0490245Y06, 0493075U02, 0493085U02, 0493435U04 0493675U04, 0493685U07, 0494465U07, 0494475U09, 0494855G01, 0495215U11 0495225U11, 0495505G02, 0495515G02, 0496535G08, 0496875G08, 0496885G08 0497245S02 0492205E03 0493695U04 0494485U07 0495525G02 0497265S02 0492765E07
The affected product lot information can be identified by product labeling on shipper and individual sterile trays.
Quest Medical, Inc. voluntarily recalled the applicable lots of MPS Delivery Sets after becoming aware of complaints alleging patient blood loss from the device during use. Quest Medical, Inc. has notified the FDA of this action.

The identified lots of MPS Delivery sets have shown a possible seal failure along the blood source channel of main pump cassette, resulting in blood loss from the bypass circuit and interruption of cardioplegia solution delivery. The firm has received twenty (20) complaints alleging this seal failure which have resulted in 16 instances of patient blood loss during surgery. There have been no reports of patient injuries as a result of the alleged issue to date. The firm has reported these events via the FDA MEDWATCH program.

Quest Medical, Inc. is notifying its distributors and customers by certified letter/return receipt and is arranging for return and replacement of all recalled product(s).

Consumers with questions may contact the company via telephone at 1-800-627-0226 Monday through Friday between the hours of 9am and 5pm (CT). Consumer may also contact the company via e-mail at custserv@questmedical.com.

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

Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Sanofi US Issues Voluntary Nationwide Recall of Auvi-Q® Due to Potential Inaccurate Dosage Delivery

Consumers: Sanofi US. 1-800-981-2491

Bridgewater, N.J. – Sanofi US is voluntarily recalling all Auvi-Q® (epinephrine injection, USP). The recall involves all Auvi-Q currently on the market and includes both the 0.15 mg and 0.3 mg strengths for hospitals, retailers and consumers. This includes lot number 2299596 through 3037230, which expire March 2016 through December 2016. The products have been found to potentially have inaccurate dosage delivery.
If a patient experiencing a serious allergic reaction (i.e., anaphylaxis) did not receive the intended dose, there could be significant health consequences, including death because anaphylaxis is a potentially life-threatening condition. As of October 26, 2015, Sanofi has received 26 reports of suspected device malfunctions in the US and Canada. None of these device malfunction reports have been confirmed. In these reports, patients have described symptoms of the underlying hypersensitivity reaction. No fatal outcomes have been reported among these cases.

Auvi-Q (epinephrine injection, USP) is used to treat life-threatening allergic reactions (anaphylaxis) in people who are at risk for or have a history of these reactions. Auvi-Q is packaged with two active devices and one trainer device in a corrugate box. Auvi-Q was distributed throughout the United States via wholesalers, pharmacies and hospitals. All Auvi-Q is being recalled.

Sanofi US is notifying its distributors and customers who include doctors, pharmacies, wholesalers and other customers in the supply chain by letter, fax, email and phone calls and is arranging for return and reimbursement of all recalled products.

Customers with questions regarding this recall can go to www.Auvi-Q.com and call 1-866-726-6340 Monday through Friday 8 a.m. to 8 p.m. ET for information about how to return their Auvi-Q devices. Customers may also email cs@sanofi.com. Sanofi US will provide reimbursement for out of pocket costs incurred for the purchase of new epinephrine auto-injectors with proof of purchase.

Customers should immediately contact their healthcare provider (HCP) for a prescription for an alternate epinephrine auto-injector. In the event of a life-threatening allergic reaction (anaphylaxis), patients should only use their Auvi-Q device if another epinephrine auto-injector is not available, and then call 911 or local medical emergency services. Customers should contact their physician or HCP if they have experienced any problems that may be related to taking or using this drug product.

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

Complete and submit the report Online: http://www.fda.gov/medwatch/report.htmdisclaimer icon
Regular Mail or Fax: Download form http://www.fda.gov/MedWatch/getforms.htmdisclaimer icon or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Sanofi US is committed to patient safety and the quality of Auvi-Q, and will continue to work closely with customers and regulatory authorities to resolve this issue in a timely manner.

Important Safety Information

Auvi-Q is for immediate self (or caregiver) administration and does not take the place of emergency medical care. Seek immediate medical treatment after use. Each Auvi-Q contains a single dose of epinephrine. Auvi-Q should only be injected into your outer thigh. DO NOT INJECT INTO BUTTOCK OR INTRAVENOUSLY. If you accidentally inject Auvi-Q into any other part of your body, seek immediate medical treatment. Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related (cardiac) symptoms.

If you take certain medicines, you may develop serious life-threatening side effects from epinephrine. Be sure to tell your doctor about all the medicines you take, especially medicines for asthma. Side effects may be increased in patients with certain medical conditions, or who take certain medicines. These include asthma, allergies, depression, thyroid disease, Parkinson’s disease, diabetes, high blood pressure, and heart disease.

The most common side effects may include increase in heart rate, stronger or irregular heartbeat, sweating, nausea and vomiting, difficulty breathing, paleness, dizziness, weakness or shakiness, headache, apprehension, nervousness, or anxiety. These side effects go away quickly, especially if you rest.

You are encouraged to report negative side effects of prescription drugs. In the US, contact the FDA by visiting www.fda.gov/medwatch disclaimer iconor call 1-800-FDA-1088.

Please click here for Full Prescribing Information.

About Sanofi US

Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi is the holding company of a consolidated group of subsidiaries and operates in the United States as Sanofi US. For more information on Sanofi US, please visit http://www.sanofi.us and http://www.news.sanofi.us/social-media or call 1-800-981-2491.

Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group’s ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2014. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Premiere Sales Group Issues Voluntary Nationwide Recall of All Lots of Rhino 7 3000 and Rhino 7 Platinum 3000 Capsules due to Undeclared Active Pharmaceutical Ingredients

Consumers: 888-550-8621

Premiere Sales Group of Santa Clarita, California is voluntarily recalling the following product to the consumer level: RHINO 7 3000 capsules packaged in a bottle containing six (6) capsules UPC: 616453150126 ALL LOT NUMBERS WITHIN EXPIRY and Rhino 7 Platinum 3000 Capsules packaged in a single (1) blister packs hang card count UPC: 700729253748 ALL LOT NUMBERS WITHIN EXPIRY. Lot numbers are on the back top right of the (1) count and on the side of the (6) count bottle.  FDA analysis found these products to contain undeclared desmethyl carbondenafil and dapoxetine.  Desmethyl carbondenafil is a phosphodiesterase PDE-5 inhibitor which is a class of drugs used to treat male erectile dysfunction, making these products unapproved new drugs.  Dapoxetine is an active ingredient not approved by the U.S. Food and Drug Administration (FDA).
Desmethyl carbondenafil may pose a threat to consumers because this PDE-5 inhibitor may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels that can be life threatening.  Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

Dapoxetine has not been approved by the FDA and therefore its safety or efficacy has not been established. Chemically, dapoxetine belongs to a class of drugs known as selective serotonin reuptake inhibitors (SSRIs) used to treat depression.  Studies have shown that antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults when compared to placebo. Therefore, consuming these products presents a health risk which could be life threatening.

Premiere Sales has not received a report of any adverse events associated with these products.

These products are marketed as dietary supplements for sexual enhancement and packaged in (6) count bottle and (1) count hanging card and distributed to consumers nationwide. Premiere Sales Group has discontinued sales of these products.

Premiere Sales Group has notified its customers of this voluntary recall via e-mail and phone.  Consumers that purchased these products from Premiere Sales Group should stop using them immediately and can return the products to : Premiere Sales Group, 21446 Golden Triangle Rd., Santa Clarita, CA 91350

Consumers with questions regarding this recall can contact Premiere Sales Group by telephone at 888-550-8621 between (Monday through Friday 7:30am to 4:00pm Pacific Standard Time Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products. Consumers can report adverse reactions or quality control problems to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax as follows:

Complete and submit reporting form online at http://www.fda.gov/MedWatch/report.htm; or
Mail or fax reporting form. Download form at http://www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form. Complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-1078.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.