FDA Recalls on Drugs
Fusion Health and Vitality Issues Voluntary Nationwide Recall of Core Essential Nutrients and Immune Boost Sublingual Vitamin D3 Due to the Unapproved Use of a Food Additive and Unapproved Marketing Statements
Fusion Health and Vitality LLC is voluntarily recalling all 2020 Lots of CORE essential nutrients and Immune Boost Sublingual Vitamin D3. CORE has been found to contain an unapproved food additive, hordenine HCl, rendering it adulterated. Immune Boost Labeling was found to contain statements that caused it to become and unapproved new drug under FDA labeling laws. Hordenine HCl is possibly unsafe when taken by mouth. Hordenine HCl might have similar stimulant effects and side effects such as rapid heart rate and high blood pressure.
Fresenius Kabi Issues Voluntary Nationwide Recall of a Single Lot of Dexmedetomidine Hydrochloride Injection Due to Cross-Contamination of Lidocaine
Fresenius Kabi USA is voluntarily recalling a single lot of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg /mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to a trace amount of lidocaine present in the lot. This recall is being performed to the user level.
To date, no adverse drug experience reports have been received for the recalled lot. Administration of Dexmedetomidine HCl containing trace amounts of lidocaine to a patient with lidocaine allergy could result in a potentially life-threatening allergic reaction.
FDA Recalls on Food & Beverages
Hong Thai Foods Corp Issues Allergy Alert on Undeclared Milk Allergens in Golden Boy Custard Muffin Pandan
Hong Thai Foods Corp. of Brooklyn, NY is recalling its 7.76 ounce packages of Golden Boy Custard Muffin Pandan because they may contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life-threatening allergic reactions if they consume this product.
The recalled Golden Boy Custard Muffin Pandan were distributed nationwide in retail stores. The product comes in a 7.76 ounce, rigid clear plastic package marked with Best Before date of 29/01/2022 on the bottom.
Vegpro International Issues a Recall of Fresh Attitude Baby Spinach Because of Potential Salmonella Health Risk
Vegpro International of Sherrington, QC CAN is recalling Fresh Attitude baby spinach (5oz and 11oz) with Best before dates of Dec 4th (for 11oz) and Dec 4th & 5th (for the 5oz), 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
These products were produced in Vegpro’s Eastern Canadian plant and have been distributed ONLY in Eastern Canada and in the Northeastern United States (NY,NJ, DE, CT,MD & PA ). All other Fresh Attitude product sold in the US is produced in Belle-Glade Florida and is not linked to this recall whatsoever and therefore safe for consumption.
Prairie Farms has issued a limited voluntary recall of its Prairie Farms Premium Flavored Chocolate Milk gallons and Prairie Farms 1% Lowfat Chocolate Milk gallons (Best by Date: Dec. 4, 2020) that were not labeled for an egg allergen that may be present. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products.
A total of 1,152 units of chocolate milk gallons (355 units of Premium Flavored Chocolate and 797 units of 1% Lowfat Chocolate) were distributed at retail outlets in the Chicago area, including the Northern Illinois Suburbs, Rockford, Illinois, and Southeastern Wisconsin.
Riverside Natural Foods LTD. Issues Allergy Alert on Undeclared Almond in "Good & Gather Banana Chocolate Chip Date & Nut Bar"
Riverside Natural Foods, of Vaughan, ON is voluntarily recalling its 8 ounce packages of " Good & Gather Banana Chocolate Chip Date & Nut Bar " because they were improperly labelled and may contain undeclared almonds. The product is labelled to may contain tree nuts; however, people who have allergies to almonds may experience a serious or life-threatening allergic reaction if they consume these products.
The recalled " Good & Gather Banana Chocolate Chip Date & Nut Bar " were distributed nationwide in retail stores and through mail orders.
Shenandoah Growers Inc Issues a Limited, Voluntary Recall of Certain Imported Organic Basil Because of Potential Health Risk
Shenandoah Growers, Inc (Harrisonburg, VA) out of an abundance of caution, has issued a limited, voluntary recall of approximately 15,000 units in select packages, due to a possible health risk from Cyclospora.
These were packed under branded and private label fresh cut organic certified basil clamshells at its Jefferson, GA facility and Harrisonburg, VA facility with the following lot codes, all with the country of origin of Colombia. Recalled products were distributed to select retail stores between 10/20/2020 and 10/30/2020 in various states including Georgia, Tennessee, Florida, Virginia, Pennsylvania, Maryland, Connecticut, Delaware, New Jersey, New York, and Washington DC.
Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling two of its Hy-Vee Short Cuts vegetable mix products across its eight-state region (IL, IA, KS, MN, MO, NE, SD, and WI) due to possible contamination with Listeria monocytogenes. The potential for contamination was discovered during routine safety sampling at Hy-Vee’s Short Cuts production facility. To date, no illnesses have been reported in connection with these products.
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 monocytogenes infection can cause miscarriages and stillbirths among pregnant women.
Allergy Alert Issued for Undeclared Shrimp in Mislabeled Popcorn Chicken from 26 Whole Foods Market Stores
Whole Foods Market is voluntarily recalling packaged popcorn chicken with sweet chili sauce across 26 stores in Northern California and Reno, Nevada. The product is being recalled because it may contain undeclared shellfish (shrimp) that was not listed on the product label due to mislabeling. People who have an allergy or severe sensitivity to shellfish run the risk of serious or life-threatening allergic reaction if they consume these products.
The affected products were sold at the below Whole Foods Market locations. The product was sold in plastic containers in the prepared foods department and was labeled as “Popcorn Chicken Shaker with Sweet Chili” with sell by dates through Nov. 27, 2020. The product can be identified by the PLU number 81789 on the scale label near the UPC. All affected product has been removed from store shelves. The issue was identified as a result of a customer complaint and one illness has been reported to date
Dole Fresh Vegetables, Inc. is voluntarily recalling a limited number of cases of organic romaine hearts. The products being recalled are Dole™ Organic Romaine Hearts 3pk (UPC 0-71430-90061-1), combined English/French packaging, with Harvested-On dates of 10-23-20 and 10-26-20, and Wild Harvest Organic Romaine Hearts (UPC 7-11535-50201-2), with Harvested-On dates of 10-23-20 and 10-26-20. The recall is being conducted due to a possible health risk from E. coli in the two products. Dole Fresh Vegetables is coordinating closely with regulatory officials. No illnesses have been reported to date in association with the recall.
Pathogenic E. coli can cause diarrhea, severe stomach cramps and vomiting. Most people recover within a week, but some illnesses can last longer and can be more severe.
The Harvested-On sticker is located on the upper right corner of each bag and the UPC code is located on the bottom right corner of the back of each bag. The Dole package contains three organic romaine hearts and the Wild Harvest product is packaged in a 12oz bag. The impacted products were distributed in AZ, HI, IA, IL, IN, KS, MD, MI, MN, MO, MS, MT, NC, ND and VA. These products were harvested and packed nearly 4 weeks ago and should no longer be in commerce. Consumers are advised to check product they have in their homes and discard any product matching the production description, UPC codes and Harvested-On dates listed above
Fresh Express Recalls Limited Quantity of Expired Fresh Express Kit Caesar Supreme Due to Potential Health Risk
Fresh Express is voluntarily recalling a limited number of cases of expired 10.5 oz. Fresh Express Kit Caesar Supreme with the Use-by Date of November 8, 2020 and Product Code S296 because it may be contaminated with Escherichia coli STEC 026 bacteria. The recall is being executed out of an abundance of caution in the unlikely event the product, which is now 8 days past the Use-By Date, is still in stores or consumers’ homes. The recalled product was distributed primarily in Western and Southwestern U.S. states.
No illnesses are reported, and no consumer complaints have been received by the Fresh Express Consumer Response Center in association with this recall. No other Fresh Express products are subject to recall.
The recall of the expired product is being conducted due to an isolated incident in which a single randomly selected package of 10.5 oz. Fresh Express Kit Caesar Supreme yielded a positive result for E. coli STEC 026.