Drug Recalls
Exela Pharma Sciences, LLC Issues Voluntary Nationwide Recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton Due to Vial Breakage
Exela Pharma Sciences, LLC, (Exela) is voluntarily recalling 49 lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20- count carton, to the consumer level.
Risk Statement: The product poses a potential safety concern with vial breakage and flying glass when pressurized while preparing the product for administration. Exela has received five (5) reports of flying glass injuring skin, eye and/or other parts. There have been no reports of sterility failures.
The product is used for treatment of metabolic acidosis and is packaged in a 50 mL glass vial, 20 vials per carton. The vials are labeled with Exela brand (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1, Figure 1) and Civica brand (Carton NDC: 72572-740-20; Vial NDC: 72572-740-1, Figure 2).
Food & Beverage Recalls
Craftology, LLC DBA Dutch Treat Foods Issues Allergy Alert on Undeclared Cashews in “Craftology This is My Happy Place Pasta Salad”
Craftology, LLC dba Dutch Treat Foods of Zeeland, MI, is recalling its 14 ounce containers of “Craftology This Is My Happy Place Pasta Salad” because they may contain undeclared cashews. People who have allergies to cashews run the risk of serious or life-threatening allergic reaction if they consume these products.
The recalled “Craftology This Is My Happy Place Pasta Salad” was distributed in the midwestern United States in retail stores.
Lipari Foods Issues Voluntary Product Recall of Specific Sesame Sticks Mix and Roasted/Salted Sunflower Meat Tubs Due to Undeclared Cashew Allergen
WARREN, Mich. – Lipari Foods has issued a voluntary recall of specific lots of sesame sticks mix and roasted and salted sunflower meat tub products packaged by sister company JLM due to an undeclared cashew (tree nut) allergen. People who have an allergy or severe sensitivity to cashews run the risk of a serious or life- threatening allergic reaction if they consume these products.
The products were distributed to retail stores throughout Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, Texas, Tennessee, Wisconsin, and West Virginia.
Products were distributed as generic product without branding.
Bakkavor USA Issues Allergy Alert for 32 Ounce Meal Simple Tomato Basil Soup for Mislabeling and Undeclared Dairy
Jessup, Pennsylvania (October 6, 2022) – Bakkavor USA of Jessup, Pennsylvania, is initiating a proactive, voluntary recall of the 32-ounce Meal Simple Tomato Basil Soup as it has been mislabeled and may contain undeclared dairy. People who have an allergy or severe sensitivity to dairy run the risk of a serious or life-threatening allergic reactions if they consume the product. The 32-ounce Meal Simple Tomato Basil Soup with the 12/2/2022 best date was sold at H-E-B stores in Texas with a label stating Meal Simple Beef Chili With Beans.
The recall was initiated after it was discovered that the front label was mislabeled for the 32-ounce Meal Simple Tomato Basil Soup, produced on 9/15/2022 with best by date of 12/2/2022 and does not contain an allergen declaration of milk, which is found in the product. The root cause investigation is ongoing and there have been no known reports of adverse reactions.
Cuisine Innovations Unlimited, LLC Issues Voluntary Recall of Two Varieties of Earth Grown Frozen Falafel Due to Possible Health Risk
Cuisine Innovations Unlimited, LLC of 180 Lehigh Avenue, Lakewood, NJ, is voluntarily recalling its Earth Grown Vegan Traditional Falafel and Garlic & Herb Falafel Distributed & Sold Exclusively by Aldi, Batavia, IL due to the possible presence of Shiga toxin-producing E. coli.
Shiga-toxin-producing E. coli is an organism that can cause foodborne illness in a person who eats a food item contaminated with it. Symptoms of infection may include stomach cramps, diarrhea, and vomiting. The illness primarily impacts elderly individuals, children, and people with weakened immune systems. Most healthy adults and children rarely become seriously ill.
The voluntarily recalled Earth Grown Vegan Traditional Falafel And Garlic & Herb Falafel Distributed & Sold Exclusively by Aldi, Batavia, IL were distributed in ALDI retail stores in the following states: Alabama, Arizona, Arkansas, California, Connecticut, Delaware, District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, West Virginia, and Wisconsin.
The product comes in a bag in a box marked with any of the following Lot numbers: 1472, 1481, 1531, 1532, 1541, 1552, 1561, 1581, 1601, 1611, 1612, 1661, 1682, 1732, 1752, 1762, 1782, 1802, and 1812, and would have been shipped to stores after June 24, 2021. The lot number can be found in the “Best if used by” area on the outside flap of the box. There has been no further production of this product.
There have been 20 reported cases in six (6) states (FL, IA, KS, MI, OH and WI) with onset dates reported between July 24, 2022 and September 19, 2022 with 5 hospitalization and no deaths.
Cut Fruit Express Recalls Caribou Coffee Fruit and Cheese Plate Because of Possible Health Risk
Cut Fruit Express of Inver Grove Heights, MN is recalling Caribou Coffee Fruit and Cheese Plate 6.2oz because of potential contamination 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.
Caribou Coffee Fruit and Cheese Plate, item #3818, 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 USED BY DATES are 9/30/2022, 10/2/2022, 10/4/2022, 10/7/2022 and 10/9/2022.
Cut Fruit Express learned that their supplier is issuing a recall on Brie Cheese for potential contamination of Listeria Monocytogenes. Cut Fruit Express is initiating a recall on the affected product that contains the recalled Brie Cheese. The affected products were shipped between September 26th through October 5th, 2022.
Flowers Foods Issues Allergy Alert on Undeclared Soy in Certain TastyKake and Mrs. Freshley’s Glazed Pies
Flowers Foods, Inc. (NYSE: FLO) is voluntarily recalling Tastykake® and Mrs. Freshley’s® glazed pies due to undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume this product.
The products being recalled were distributed from Sept. 26, 2022 through Oct. 6, 2022 to retail and vending customers throughout the U.S., Canada, and Mexico. The packages have either an “Enjoy By” date of 10/28/2022 through 11/07/2022 and/or product codes 307 2263 through 307 2274 printed on the front of the packages. The UPC codes are printed on the back of the packages.
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