FOR IMMEDIATE RELEASE – October 31, 2023 – La Vergne, TN, The Harvard Drug Group, LLC d/b/a Major® Pharmaceutical and Rugby® Laboratories is initiating a voluntarily recall for all lots of Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) supplied by Velocity Pharma, LLC to the consumer level. The Harvard Drug Group, LLC received information from FDA indicating investigator found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility.

Risk Statement: For those patients who use these products, there is a potential risk of eye infections that could result in partial vision loss of blindness. These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drug applied to the eyes bypass some of the body’s natural defenses. The Harvard Drug Group, LLC has received three (3) reports of adverse events related to these products including reports of vision blurriness, vision loss, and burning eyes. The reports of adverse events were shared with our supplier, Velocity Pharma, LLC.

Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) are available as over the counter (OTC) products used for temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun and the product used as a protectant against further irritation or to relieve dryness of the eye.

Both Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) can be identified on the outer carton labeling as follows:

Images of the outer carton labelling of both Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) can be found below.

Products were distributed Nationwide starting June 1, 2021.

The Harvard Drug Group, LLC is notifying all impacted direct accounts via mail of this voluntary recall and is arranging for return of all recalled products listed above. Wholesalers, Distributors and Retailers that have the affected product which is being recalled should cease distribution of the products. Consumers should stop using the recalled eye drop products and may return any of the above listed products to the place of purchase.

Consumers with questions regarding this recall can contact Sedgwick, Inc. by phone at 1- 866-891-1981 (8:00am-5:00pm EST Monday through Friday) or by email address harvarddrug8430@sedgwick.com. Consumers who have signs or symptoms of an eye infection after using these products should talk to their health care provider or seek medical care immediately.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/harvard-drug-group-llc-issues-voluntary-nationwide-recall-certain-rugbyr-laboratories-brand-eye

Orgain LLC of Irvine, CA is voluntarily recalling a limited production run of its Organic Protein Powder + Superfoods, Creamy Chocolate Fudge flavor, because it may contain an undeclared sesame allergen.

People who have a sesame allergy or severe sensitivity to sesame run the risk of serious or life-threatening allergic reaction if they consume this product. Protein Powder + Superfoods, Creamy Chocolate Fudge 43.8 ounce/2.64 lb. is an item exclusively sold at Costco. The impacted product is limited to four lots and has been traced to select Costco warehouse locations, but not to Costco’s e-commerce site. No other Orgain products or retailers are affected by this voluntary recall.

No illnesses have been reported to date.

A co-manufacturer inadvertently used sesame in a limited production of Orgain’s Organic Protein + Superfoods, Creamy Chocolate Fudge flavor. The co-manufacturer informed Orgain that the product was distributed with an undeclared sesame allergen and Orgain initiated the recall.

Orgain is working closely with Costco and the U.S. Food and Drug Administration (FDA) on this recall. Costco has notified its members who purchased the affected product between September 8th – 28th.

We recommend that consumers return any unused product marked with the below lot numbers and expiration dates to a local Costco for a full refund. The product comes in a 43.8 ounce/2.64 lb., white plastic package marked with the lot number and expiration date printed on the bottom.

The impacted product was distributed to select Costco warehouse locations between September 8th -28th in Alabama, Alaska, California, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Missouri, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Washington D.C., and Wisconsin.

Please contact the Orgain Consumer Care Team at 888-881-4246 or support@orgain.com, Monday through Friday between 8-11 am and 12-5 pm Pacific, for any questions and support.

Consumers:

Orgain Consumer Care Team

888-881-4246

 support@orgain.com

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/orgain-issues-allergy-alert-undeclared-sesame-organic-plant-protein-superfoods-powder-creamy

Yarnell Operations LLC of Searcy, Arkansas, today said it is voluntarily recalling containers of Yarnell’s Guilt Free No Sugar Added Homemade Vanilla Ice Cream (48 ounces/1.5 quart) because the product may contain undeclared egg. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reactions if they consume this product.

The product was distributed to Walmart, Kroger, Harps, Edwards Food Giants, Hays, Mad Butchers, Cash Savers, Hometowns, Superlo, Shoppers Value, Town & Country Supermarket and G&W Foods retail stores in Arkansas, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Oklahoma, Tennessee and Texas.

The ice cream is packaged in a round container with a UPC of 0-70905-48521-9.

An example of the container and lid has been included with this release. The following “best buy” dates are included in the recall:

Best by 11/15/2024 – Lot 3135
Best by 11/16/2024 – Lot 3136
Best by 02/04/2025 – Lot 3216

The “best by” dates are located on the bottom of the container. An example of the best by date is included below:

BEST BY 11/16/2024
05-50 3136 05:58 00000

There have been no illnesses reported to date.

The recall was initiated after it was discovered during a label review that the product may contain undeclared egg.

Customers who have purchased this product may return the product to the store it was purchased from for a full refund.

Customers requiring additional information may contact Yarnell Customer Service Monday through Friday from 8 a.m. to 5 p.m. EST at 1-855-215-5039.

About Yarnell’s Ice Cream

Yarnell’s Ice Cream is an Arkansas tradition. Care, detail and a touch of southern flair go into each and every one of its premium ice cream products. Yarnell’s Premium Ice Cream Company of Searcy traces its roots back to 1932. The company was owned and operated by four generations of the Yarnell’s family and was purchased in November 2011 by Schulze & Burch Biscuit Company, with operations in Chicago and Searcy. The Yarnell’s brand relaunched in spring 2012, using the same original formulas and beloved recipes. Products include the “Premium Red” ice cream line offering customer favorites and bestsellers, frozen yogurt with five live active cultures, guilt-free ice cream that is low in fat with no sugar added, and ice cream sandwiches. Yarnell’s Premium Ice Cream can be found in Walmart, Kroger and Harps stores, as well as many independent grocers throughout the state and Mid-South region.

Consumers:

Yarnell Customer Service

1-855-215-5039

Media:

Stephen Podracky

773-650-6733

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/yarnell-operations-issues-allergy-alert-undeclared-egg-ice-cream

Don Miguel Foods, a Dallas, Texas establishment, is recalling approximately 10,642 pounds of frozen ready-to-eat (RTE) carne asada burrito products that may be adulterated with LISTERIA MONOCYTOGENES, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The frozen RTE carne asada burrito items were produced on September 27, 2023. The following products are subject to recall [view labels]:

• 7-oz. individual wax paper packages containing “DON MIGUEL Hand Made BURRITO CARNE ASADA” with date code D23270 printed on the package.

The products subject to recall bear establishment number “EST. 20049” inside the USDA mark of inspection. These items were shipped to retail convenience store locations nationwide.

The problem was discovered after the establishment’s laboratory testing indicated the product may be contaminated with LISTERIA MONOCYTOGENES. The establishment notified FSIS that some of the affected product was distributed into commerce.

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.

Consumption of food contaminated with L. MONOCYTOGENES can cause listeriosis, a serious infection that primarily affects older adults, persons with weakened immune systems, and pregnant women and their newborns. Less commonly, persons outside these risk groups are affected.

Listeriosis can cause fever, muscle aches, headache, stiff neck, confusion, loss of balance and convulsions sometimes preceded by diarrhea or other gastrointestinal symptoms. An invasive infection spreads beyond the gastrointestinal tract. In pregnant women, the infection can cause miscarriages, stillbirths, premature delivery or life-threatening infection of the newborn. In addition, serious and sometimes fatal infections in older adults and persons with weakened immune systems. Listeriosis is treated with antibiotics. Persons in the higher-risk categories who experience flu-like symptoms within two months after eating contaminated food should seek medical care and tell the health care provider about eating the contaminated food.

FSIS is concerned that some product may be in consumers’ freezers. 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.

Media with questions regarding the recall can contact Don Miguel Foods Media Relations at media@mmxfoods.com. Consumers with questions regarding the recall can contact Don Miguel Foods Consumer Engagement, at 800-523-4635 or www.megamexfoods.com/contact-us/.

Consumers with food safety questions can call the toll-free USDA Meat and Poultry Hotline at 888-MPHotline (888-674-6854) or send a question via email to MPHotline@usda.gov. For consumers that need to report a problem with a meat, poultry, or egg product, the online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at https://foodcomplaint.fsis.usda.gov/eCCF/.

https://urldefense.com/v3/__https://www.fsis.usda.gov/recalls-alerts/don-miguel-foods-recalls-frozen-ready-eat-carne-asada-burrito-products-due-possible__;!!EErPFA7f–AJOw!Fm2lY2BlnHAuBIl_aGdfeA7OHs07ivcEfw4uLTpSZg0F3dtlJAEnWLLyD6c5NUXAoE3HmtPl7SbjJW4KHkM6cCxpqDfQFvo$

Company Announcement

Utopia Foods Inc of Glendale, NY, is recalling all lots within expiry of Qilu Enterprise branded 200g packages of “Enoki Mushrooms” 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 high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, LISTERIA MONOCYTOGENES infection can cause miscarriages and stillbirths among pregnant women.

The recalled Enoki Mushrooms were distributed to produce wholesalers in NY, NJ, PA, MA and MD. Products may have been further distributed to retail locations such as grocery stores.

The product comes in a 200g, clear plastic package with barcode 8928918610109 marked on the packaging. All products within expiry are included in the recall and were distributed between 8/7/2023 and 10/20/2023.

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

The potential contamination was noted by a routine sampling conducted by the State of West Virginia on products which were further distributed by Utopia’s customers bearing expiration date 10/26/2023. The products tested positive for LISTERIA MONOCYTOGENES.

Utopia Foods had suspended the distribution of the products and initiated a full-range recall for all expiration dates.

Consumers who have purchased the 200g packages of “Enoki Mushrooms” are urged to return them to the place of purchase for a refund. Consumers with questions may contact the company at 718.389.8898 Monday-Friday EST 8AM-5PM.

Consumers:

Utopia Foods Inc., Jack

718.389.8898

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/utopia-foods-recalls-enoki-mushrooms-because-possible-health-risk-0

Eagle Produce LLC Scottsdale, AZ is initiating a voluntary recall of 6,456 cases of whole cantaloupe with the potential to be contaminated with SALMONELLA following a test conducted on cantaloupe in a distribution center by the FDA. 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 producing more severe illness such as arterial infections (i.e. infected aneurysms), endocarditis and arthritis.

The cantaloupe subject to the recall include:

The products were distributed between September 5th -16th in California, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Ohio, South Dakota, Tennessee, Texas, Virginia, West Virginia, Wisconsin and Washington D.C. and sold in various retail supermarkets.

No other products or lot code dates are affected by this recall. The company is cooperating with the FDA regarding this recall.

There have been no reported illnesses attributed to the recalled items as of September 27th, 2023

Customers who have purchased these products are urged not to consume the products and should dispose of them. Consumers may contact Eagle Produce LLC for further information at 1-800-627-8674 Monday – Friday 9 AM – 5PM PST. Consumers with concerns about an illness from consumption of this product should contact a health care provider.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/eagle-produce-llc-recalls-whole-cantaloupe-because-possible-health-risk

Kraft Heinz is announcing a voluntary recall of approximately 83,800 cases of individually-wrapped Kraft Singles American processed cheese slices that were shipped to a limited number of customers.

The voluntary recall comes as a precaution after a temporary issue developed on one of our wrapping machines, making it possible that a thin strip of the individual film may remain on the slice after the wrapper has been removed. If the film sticks to the slice and is not removed, it could be unpleasant and potentially cause a gagging or choking hazard.

Only Kraft Singles American processed cheese slices with the case/package information below are affected. No other varieties or sizes are included in the recall.

The issue was discovered after we received several consumer complaints about finding the plastic stuck to a slice, including six complaints of consumers saying they choked or gagged in connection with the issue. No injuries or serious health issues have been reported.

Kraft Heinz has fixed the machine that wrapped the affected slices and all other processing machines have been thoroughly inspected.

Consumers who purchased these items should not consume them and can return them to the store where it was purchased for an exchange or refund. Consumers can contact Kraft Heinz from 9 a.m. to 6 p.m. Eastern Standard Time, Monday through Friday, at 1-800-280-8252 to see if a product is part of the recall and to receive reimbursement.

Kraft Heinz is committed to upholding the highest safety and quality standards and apologizes for this inconvenience.

Products included in the recall include 16 oz. Kraft Singles American Pasteurized Prepared Cheese Product with an individual package UPC of 0 2100061526 1 and a “Best When Used By” date of 10 JAN 24 through 27 JAN 24. Individual packages in this recall will contain an S and 72 in the Manufacturing code.

Also included in the recall are 3 lb. multipacks of Kraft Singles American Pasteurized Prepared Cheese Product with a carton UPC of 0 2100060491 3 and a “Best When Used By” of 09 JAN 2024 through 13 JAN 2024 and 16 JAN 2024.

David’s Cookies is recalling 960 units of “Marketside Chocolate Chip Explosion Cake” lot # BS23212 that has been sold in Walmart retail stores across the country.

This recall is due to that the 960 units of “Marketside Ultimate Peanut Butter Chocolate Cake” ware mislabeled with a label as “Marketside Chocolate Chip Explosion Cake” a name that does not depict peanut as a key ingredient and does not declare the peanut allergen warning on the label.

The product is in a 7-ounce, clear plastic package marked with lot # BS23212 on the top of the package. Photo below:

No illnesses or injuries have been reported to date in connection with this mislabel. If there are any consumers with concerns about illness or injury associated with this product, please contact a physician immediately.

Subsequent investigation indicates the problem was caused at the labeling & packaging stage.

In coordination with Walmart, they have blocked all Marketside Ultimate Peanut Butter Chocolate Cake and Marketside Chocolate Chip Explosion Cake from their distribution centers and store registers, so no consumer is able to purchase either of these products until further investigation and resolutions have been completed by David’s Cookies and Walmart.

Consumers who have purchased the 7.9 oz Marketside Chocolate Chip Explosion Cake, lot # BS23212, are urged to return them to the location of purchase for a full refund. Consumers with questions may contact David’s Cookies at 800-500-2800. Business hours are from 8:30 am to 5:00 am, DST Eastern time zone.

The Walmart distribution center distributing the mislabeled product has been identified and David’s Cookies and Walmart will continue to work to correct the situation and prevent further shipments to stores.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/allergen-alert-undeclared-peanuts-cake