Drug Recalls
Meta Herbal Issues Voluntary Nationwide Recall of Magnum XXL 9800 Capsules Due to Presence of Undeclared Sildenafil
FOR IMMEDIATE RELEASE – November 28, 2023 – E. Hampton NY- Meta Herbal is voluntarily recalling 500 blister packs of Magnum XXL 9800 2000 mg per capsule, to the consumer level. The products have been found to be tainted with Sildenafil. Sildenafil is an ingredient known as a Phosphodiesterase Inhibitor (PDE-5) found in FDA-approved products for the treatment of male erectile dysfunction. Products containing sildenafil cannot be marketed as dietary supplements. Magnum XXL 9800 capsules is an unapproved new drug for which safety and efficacy has not been established and, therefore, subject to recall.
Novartis Issues Voluntary US Nationwide Recall of Two Lots of Sandimmune® Oral Solution (Cyclosporine Oral Solution, USP), 100 mg/mL Due to Crystallization
FOR IMMEDIATE RELEASE – November 24, 2023 - East Hanover, NJ — Novartis is conducting a voluntary nationwide recall at the consumer level of two lots of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the US due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. The issue was identified during an investigation of crystallization in a different lot of Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL. No other Sandimmune formulations are impacted.
Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL, packaged in 50 mL bottles, is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents.
Food & Beverage Recalls
Allergy Alert for Undeclared Peanut in Maggi 2 Minute Noodles
New India Bazar, Milpitas, CA is recalling 2,400 packets of Maggi 2 Minute Noodles 280g and 1,200 packets Maggi 2 Minute Noodles 560g, because it may contain undeclared Peanut allergen. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.
Maggi 2 Minute Noodles was distributed to our retail stores listed below:
New India Bazar-2213 El Camino Real, Santa Clara, CA 95050-(408)249-2599
New India Bazar-440 S Main St, Milpitas, CA 95035-(408)262-5300
New India Bazar-3160 Santa Rita Rd, Pleasanton, CA 94566-(925)461-3000
New India Bazar-4552 Dublin Blvd, Dublin, CA 94568-(925)875-1692
New India Bazar-5113 Mowry Ave, Fremont, CA (510)742-0555
New India Bazar-2850 Quimby Rd, San Jose, CA (408)223-9978
This product is packed in a yellow plastic pouch and comes in two different packaging: 280 grams and 560 grams. The product has a label with the specific name Maggie 2 Minute Noodles. The 280 grams Packaging has an expiration date of December 2023, and the packaging 560 grams has an expiration date of January 2024. So far no illnesses have been reported to this date.
The recall was initiated after it was discovered that Maggie 2-minute noodle 280 grams and 560 grams Packaging contains peanuts, which was distributed in such packaging, and the packaging didn’t reveal the presence of peanuts.
Pacific Trellis Fruit Recalls Malichita Brand Cantaloupes Due to Possible Health Risk
Los Angeles, CA, December 1, 2023…Pacific Trellis Fruit, LLC is initiating a voluntary recall of 4,872 cases of Malichita brand whole cantaloupe. The voluntary recall is due to the FDAs ongoing investigation of an outbreak involving Malichita brand cantaloupe. The cantaloupes have the potential to be contaminated with Salmonella. 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 produce more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
The products were distributed between October 18th - 26th in California, Illinois, Oklahoma, Texas, Wisconsin, and Canada and sold in various retail supermarkets. The whole cantaloupe is packed in corrugated cartons, the price look-up sticker is labeled “Malichita.”
Cut Fruit Express Recalls "Fresh Cut Fruit Mix Containing Cantaloupe" Because of Possible Health Risk
Cut Fruit Express Inc. of Inver Grove Heights, MN, is recalling Caribou Coffee Fruit Mix CHPG 6.5oz, and Cut Fruit Express Brand of 6.5oz, 15oz, 16oz, 32oz packages of Fruit Mix contains Cantaloupes and Food service packages of 5lb tray, 10lb bag, 25lb Pail, 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.
Caribou Coffee Fruit Mix CHPG 6.5oz was distributed from Caribou Stores at the MSP Airport Caribou locations in the MSP Airport, Minnesota. The product comes in a clear plastic package. The USE BY DATE was 11/4/23. The remainder of the recalled "Fresh Cut Fruit Mix containing Cantaloupes" under Cut Fruit Express and food service packaging was distributed through in MN, WI and IL via retail and food service delivery. The USE BY DATES were 11/4/23, 11/5/23 and 11/6/23.
The retail product comes in with Use by Date 11/4/23, 11/5/23, 11/6/23 on the top label and food service product comes with a date label of 11/3/23 on the bag, tray or a label with use by date on the pail.
Manischewitz Issues a Product Mislabeling Advisory and Voluntary Recall on Some Very Limited Units of their Dark Chocolate Coins
Bayonne, NJ. (December 1st , 2023) – Manischewitz, is recalling Manischewitz Dark Chocolate Coins because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk, run the risk of serious or life-threatening allergic reaction if they consume these products.
The Manischewitz Dark Chocolate Coins were distributed to stores nationwide, predominately located in the New York, New Jersey and Connecticut regions, during the weeks of September 26th, 2023 through November 28th, 2023.
This recall was initiated after the company was notified by their Quantity Control Department that a limited number of bags labeled as “Dark Chocolate Coins” contained Milk Chocolate Coins, which contains milk allergen that is not declared on the label. All dairy Milk Chocolate Coins are wrapped in Gold Foil within a Blue Netting and all non-dairy Dark Chocolate Coins are wrapped in Silver Foil within a Red Netting.
Only packages bearing the Lot Code below, may potentially have gold (dairy) coins in the “dark-chocolate tagged” bag.
Bix Produce Issues Safety Alert on Cut Cantaloupe Products Due to Potential Salmonella Contamination
Little Canada, MN., Nov. 27, 2023 – Bix Produce of Little Canada, MN., is issuing a voluntary recall of Grab N’ Go containers of cut cantaloupe and mixed fruit cups due to the potential for Salmonella contamination in the products. These cantaloupe products were derived from cantaloupes that are involved in the recent Malachita cantaloupe recall.
- Consumers, restaurants, retailers, and wholesalers should not eat, sell, or serve recalled cantaloupe or recalled products containing cantaloupe.
- Consumers who may have frozen cantaloupe or cantaloupe products for later use should check their freezers and throw away any recalled products.
- If you cannot tell if your cantaloupe is part of the recall, do not eat or use it. Throw it away.
The affected cantaloupe products were distributed from October 19th through October 20th, 2023, and were sold in the states of Minnesota, North Dakota, South Dakota, and Wisconsin at convenience stores, delis, and business cafes. These products are beyond their usable shelf-life and are no longer expected to be in commerce.
Gaws Gourmet Foods Issues Allergy Alert on Undeclared Sesame in Sandwiches
Gaws Gourmet Foods of Marysville, MI, is recalling three varieties of 8” deli subs, and two varieties of breakfast bagel sandwiches because they may contain undeclared sesame.
People who have an allergy or sensitivity to sesame run the risk of serious or life-threatening allergic reaction if they consume these products.
The recalled subs and sandwiches were distributed and also sold by retail stores and bars in southeast Michigan.
The products are in a clear plastic wrap and marked with an expiration dates of 11-28 thru 12-15 marked on the back of the packaging.
Gaw’s Deluxe Italian sub 12oz UPC:1725600910, Gaw’s Classic Italian sub 8oz UPC:1725600920, Gaw’s XL Ham & Cheese sub 8oz UPC: 1725600925 Gaw’s Ham & Cheddar Bagel 6oz UPC:1725600500, Gaw’s Salami & Cheese Bagel 6oz UPC:1725600501.
Doctors Scientific Organica Announces Voluntary Recall of Limited Quantity of Burn Boot Camp Afterburn Grass-Fed Whey Protein Bars (60 grams) Due to Potential Presence of Foreign Material
Riviera Beach, FL – Doctors Scientific Organica is initiating a voluntary recall of a limited quantity of Burn Boot Camp Afterburn Grass-Fed Whey Protein Bars (60 grams) Triple Chocolate Almond flavor products due to the potential presence of foreign material, including disposable hairnet, shrink wrap and parchment paper. Foodborne foreign objects that are flexible and not sharp may cause minor injuries such as transient choking or gastrointestinal system injury.
This voluntary recall is isolated to 3 batches of Burn Boot Camp Afterburn Grass-Fed Whey Protein Bars (60 grams) Triple Chocolate Almond flavor products manufactured by Doctors Scientific Organica. This product was distributed through Burn Bootcamp retail locations, as well as online through its website to locations throughout the U.S. This recall does not involve any other products, including other varieties or flavors of protein bars.
GHGA, LLC, in Coordination with Sofia Produce, LLC DBA Trufresh, Voluntarily Recalls Select Fresh-Cut Fruit Products Due to Possible Salmonella Contamination
CONLEY, GA – November 29, 2023 - GHGA, LLC is voluntarily recalling select fresh-cut products made from whole cantaloupe subject to a previously announced product recall initiated by Sofia Produce, LLC dba Trufresh, due to potential Salmonella contamination.
Kwik Trip, Inc. Recalls Specific Fruit Cups and Trays Due to Potential Salmonella Contamination
FOR IMMEDIATE RELEASE – November 27, 2023 – Kwik Trip, Inc. has initiated a voluntary recall of three varieties of fresh-cut fruit cup and tray products listed below because they contain cantaloupe from TruFresh which has the potential to be contaminated with Salmonella.
Agriculture Department Warns Consumers To Discard “Hilltop Meadow Farm” Brand Contaminated ‘60 Day Aged Pepper Jack Raw Milk Cheese’
Harrisburg, PA – The Pennsylvania Department of Agriculture warns that consumers should discard "Hilltop Meadow Farm" brand '60 Day Aged Pepper Jack Raw Milk Cheese' with sell by dates of 9/21/2023 or earlier. Testing of this cheese confirmed the presence of Listeria monocytogenes bacteria. The Pepper Jack Raw Milk Cheese from Hilltop Meadow Farm, 153 martin Road, Pine Grove, Schuylkill County, is being voluntarily recalled by the farm, and was sold in ½ lb, 1 lb, 2.5 lb, and 5 lb sizes at their on-farm store and at the following locations:
Meadow Run Farms, 727 Rettew Mill Road, Littitz, Lancaster County
Shady Acres Farm Market, 8514 Elizabethtown Road, Elizabethtown, Lancaster County
Willow Haven Farm, 7686 Herber Road, New Tripoli, Leigh County
Healthy Habits Natural Market, 1120 Center Turnpike, Orwigsburg, Schuylkill County
Little Leaf Natural Products, 505 S Main Street, Montrose, Susquehanna County
Whole Earth Center, 360 Nassau St, Princeton, New Jersey
Healthy Way, 396 S Main St, Massena, New York
Northstar Bison Store, 225 Birch Avenue, Cameron, Wisconsin
The tainted Pepper Jack Raw Milk Cheese is labeled with the Hilltop Meadow Farm label and designations "From A2/A2 Milk" and "Made from 100% Grassfed Cow's Milk" product descriptions.
Medical Device Recalls
Baxter Issues Urgent Medical Device Correction for Novum IQ Syringe Infusion Pump Due to Potential Impact of Downstream Occlusions on Infusion Volume
DEERFIELD, Ill., NOVEMBER 29, 2023 – Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the Novum IQ syringe infusion pump. The Correction is due to the potential for an incomplete infusion following one or more downstream occlusion alarms. Baxter notified impacted customers in October and is developing a software upgrade to resolve the issue. There have been no reports of serious injury associated with this issue to date.
Baxter has identified that after one or more downstream occlusion alarms occur on the Novum IQ syringe pump, the pump may display an “Infusion Complete” alarm despite fluid remaining in the syringe. This could lead to an underdose and/or interruption of therapy. The difference between the remaining volume to be infused displayed on the pump and the volume left in the syringe is dependent on the number of occlusion alarms encountered during an infusion and the size of the syringe being used.
If a patient does not receive the intended dose of a prescribed medication, serious or critical adverse health consequences may occur. Potential health consequences are dependent on multiple patient-specific factors (such as disease state as well as age and weight of the patient involved, and the care area where they are treated), occlusion pressure settings, the number of occlusions that occurred, the size of the syringe used, and the therapy being delivered.
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