April 22

Category: 

Drug Recalls

BD Announces the Voluntary Recall of Specified Lots of ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator in the United States and U.S. Territories Due to Defective Applicator

BD (Becton, Dickinson and Company), a leading global medical technology company, is voluntarily recalling specified lots of the ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator (2% w/w chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) to the user level due to a defective applicator. The product is used as an antiseptic for the preparation of the patient's skin prior to surgery to help reduce bacteria that potentially can cause skin infection.

The ChloraPrep™ 26 mL Applicator contains glass ampules that house the sterile ChloraPrep™ solution. In normal circumstances, the product is activated by squeezing the wing on the applicator to break the ampule, which releases the solution to the sponge head for application to the patient’s skin. In certain lots, the applicator end cap was improperly secured due to a manufacturing error. This can result in broken glass and solution dropping out of the applicator once activated. In some cases, the glass ampules can drop out before activation and shatter if striking a hard surface, resulting in solution and glass fragments scattering in the procedure area and potentially causing injury to patients and health care professionals. These products were distributed in the United States and Puerto Rico.

Durisan Announces a Voluntary Recall Expansion of its Antimicrobial Hand Sanitizer

Sanit Technologies LLC d/b/a Durisan announces a voluntary recall expansion of its Durisan Antimicrobial Hand Sanitizer, NonAlcohol products in various sizes listed to now include products that have not yet expired. The products are being recalled due to out of specification microbial contamination. The issue was discovered during a routine audit.

Food & Beverage Recalls

Guan’s Mushroom Co Recalls Enoki Because of Possible Health Risk

Guan’s Mushroom Co of Commerce, CA is recalling all cases of its 200g/7.05-ounce packages of Enoki Mushroom (Product of China) because it has 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 infection can cause miscarriages and stillbirths among pregnant women.

The recalled products were distributed from CA, NY, PA through produce distributors or wholesalers to retail stores nationwide.

Church & Dwight Initiates Voluntary Recall of Select Vitamins Due to Isolated Manufacturing Issue

EWING, N.J – Church & Dwight Co., Inc. (NYSE:CHD) today initiated a voluntary recall of select vitafusion gummy products after the Company’s investigation of two consumer reports identified the possible presence of a metallic mesh material in product lots manufactured in a four-day period between October 29 and November 3, 2020. The Company is not aware of any reports of consumer illness or injury to-date. In some severe cases, ingesting a metallic material could lead to damage of the digestive tract.

Church & Dwight is coordinating closely with the U.S. Food & Drug Administration (FDA) and following all relevant protocols. The recalled gummy vitamin products are listed below with the Universal Product Code (UPC) and Lot Code. No other products are included in this recall. These products were distributed to in-store and e-commerce retailers from November 13, 2020 through April 9, 2021.

Shearer’s Foods LLC Issues Allergy Alert on Undeclared Milk in Raley’s Salt & Vinegar Flavored Potato Chips

Shearer’s Foods LLC of Massillon, OH is voluntarily recalling two lots of 9.5 ounce bags of “Raley’s Salt & Vinegar Flavored Potato Chips,” because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume this product.

Raley’s Salt & Vinegar Flavored Potato Chips were distributed at Raley’s retail stores in: CA

Creative Foods Inc Issues Allergy Alert on Undeclared Hazelnut, Peanut And Barley (Gluten) In Two Coffee Substitute Gluten-Free Products

Creative Foods Inc. of Prineville, Oregon is recalling two products, Bueno Coffee Substitute Creamy Hazelnut and Bueno Coffee Substitute Pecan Praline. They both may contain undeclared peanut, hazelnut, and/or barley (gluten). While any gluten-containing product can cause health problems for individuals with celiac disease and other gluten sensitivities. People who have hazelnut or peanut allergy run a risk of serious or life-threatening allergic reaction if they consume these products.

Bueno Coffee Substitute Creamy Hazelnut product contains undeclared peanut and hazelnut. Bueno Coffee Substitute Pecan Praline product contains undeclared peanut and barley (which contains gluten). We are recalling all products that have a sell by date of April 8, 2023 or earlier.

Jose Madrid Salsa Issues a Voluntary Recall Due to an Undeclared Anchovy Allergen

Jose Madrid Salsa in Zanesville, Ohio is voluntarily recalling its Strawberry Mild salsa, packaged in 13oz glass jars, due to an undeclared anchovy allergen.  

Products were available for sale from 3/26/2018-3/29/2021 at farmers markets, josemadridsalsa.comExternal Link Disclaimer and at the following retail locations:

Collins Greenhouse, Mount Vernon, OH

Oberlin IGA, Oberlin, OH

Cornell’s Foods, Huron, OH

Prater’s Highway Market, Adams Mills, OH
Edinberg Corner Store, Rootstown, OH

Ridgewood General Store, West Lafayette, OH
Fields Grocery, West Mansfield, OH

Sweet Berry Fresh Market, Wickliffe, OH
Lancaster Greenhouse, Lancaster, OH

Weiland’s Market, Columbus, OH
Maser’s Farm Market, Powell, OH

Zagara’s Marketplace, Cleveland Hts, OH

Blount Fine Foods Voluntarily Recalls a Limited Amount (a Single Lot) of Lobster Bisque Due to Possible Undeclared Egg Allergen

Blount Fine Foods announced that, in partnership with the FDA, it is voluntarily recalling a limited amount (a single lot—2,987 cases total) of 16 oz. Panera at Home Lobster Bisque due to potential contamination with an undeclared egg allergen. The recall is limited to 1 SKU of 16 oz. Panera at Home Lobster Bisque cups produced with lot number 030821-11K and “Use By” date of 5/17/2021. This item is only sold in refrigerated cases in the deli department of grocery-retail stores; it is NOT sold at any Panera bakery-cafe.

Lake Champlain Chocolates Voluntarily Recalls Mr. Goodtime Bunny With Best By Date 11/20/2021 for Undeclared Almonds

Lake Champlain Chocolates (LCC) is issuing a public alert and a voluntary recall on a mis-labeled Mr. Goodtime Bunny with a Best By date of 11/20/21 that may have been purchased between 2/22/21-3/25/21. LCC is issuing this recall after a consumer reported that the product contained almonds, which were not declared on the label.

Any consumer who has a known nut allergy and purchased the Mr. Goodtime Bunny with a Best By date of 11/20/21 should not consume this product.

Snak King Corporation Issues Allergy Alert on Undeclared Milk Allergen in Trader Joe’s Restaurant Style White Corn Tortilla Chips - Expanded to Include 8/11/21 Code Date

Snak King Corporation of City of Industry, CA is voluntarily recalling 9 ounce packages of “Trader Joe’s Restaurant Style White Corn Tortilla Chips” with a sell by date of 08/09/21 and 08/10/21 due to a potential of an undeclared milk allergen.  People who have an allergy or sensitivity to milk may risk serious or life-threatening allergic reaction if they consume this product.

The recalled products were sold Trader Joe’s retail stores in the following states;  AL, AZ, AR, CA, CO, DC, DE, ID, KS, LA, MD, NJ, NM, NV, NY, OK, OR, PA, TN, TX, UT, VA, WA.

Urgent: Torn & Glasser Recalls Dark Chocolate Espresso Beans Because of Undeclared Walnut Allergen

Torn & Glasser of Los Angeles, CA is recalling 7464 units of dark chocolate espresso beans due to an undeclared allergen. The dark chocolate walnuts were mislabeled as “dark chocolate espresso beans”. People who have an allergy or severe sensitivity to walnuts run the risk of serious or life-threatening allergic reaction if they consume this product.

No illnesses have been reported to date.

The mislabeled dark chocolate espresso beans were sold at Kroger divisions in the following 30 states under the banners (Kroger, Arlan’s, Fred Meyer, Smiths, Food For Less. Fry’s Food Stores, Ralphs, Dillons, Roundy’s Chicago, Roundy’s Mariano’s) beginning March 3rd, 2021.

Alaska, Alabama, Arizona, Arkansas, California, Georgia, Illinois, Indiana, Idaho, Kansas, Kentucky, Louisiana, Michigan, Mississippi, Missouri, Montana, Nebraska, Nevada, New Mexico, Ohio, Oregon, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming

Medical Devices Recalls

Tenacore LLC Issues Nationwide Recall of Tenacore’s Replacement for the Front Bezel Assembly of the CareFusion Alaris 8100 Infusion Pump Module

On February 24th, 2021, Tenacore LLC initiated a nationwide recall of 2001 Tenacore replacement CareFusion Alaris 8100 bezels due to potentially weakened plastic. A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as other damage to the bezel (e.g., external cracking). The separation of one or more bezel posts may result in free flow, over infusion, under infusion or interruption of infusion.