Cooked Butterfly Tail-On Whiteleg Shrimp (Sushi Ebi), Lot #2019.10.02

Posted by jbushland on

Summary

Company Announcement Date:
March 13, 2020
FDA Publish Date:
March 14, 2020
Product Type:
Food & Beverages
Reason for Announcement:
Potential to be contaminated with Listeria monocytogenes
Company Name:
AFC Distribution Corp.
Brand Name:
AFC Distribution Corp.
Product Description:
Cooked Butterfly Tail-On Whiteleg Shrimp (Sushi Ebi)

Company Announcement

AFC Distribution Corp. (“AFC”) of Rancho Dominguez, California is voluntary recalling Cooked Butterfly Tail-On Whiteleg Shrimp (Sushi Ebi), Lot #2019.10.02, utilized in various prepared menu offerings with sell-by dates ranging from 02/19/2020 to 03/13/2020, because this ingredient may have a potential to be contaminated with Vibrio parahaemolyticus. Vibrio parahaemolyticus is an organism which can cause illnesses such as nausea, vomiting, diarrhea, fever and chills.

The recalled ingredient, Cooked Butterfly Tail-On Whiteleg Shrimp (Sushi Ebi), was distributed to designated retail AFC sushi counters, where it is further processed into prepared sushi items, within grocery stores, cafeterias, and corporate dining centers in the following states: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, AD, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NM, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WY.

To date there have been no confirmed illnesses. (more…)

Winco Foods, Llc. Recalls Frozen Blackberries and Frozen Berry Medley Because of Possible Health Risk

Posted by jbushland on

Summary

Company Announcement Date:
March 13, 2020
FDA Publish Date:
March 13, 2020
Product Type:
Food & Beverages
Reason for Announcement:
Norovirus
Company Name:
WinCo Foods, LLC
Brand Name:
WinCo
Product Description:
Frozen Blackberries and Frozen Berry Medley

Company Announcement

March 13th, 2020, WinCo Foods, LLC. of Boise, ID is recalling frozen Blackberries in a 16 oz. bag and frozen Berry Medley in 16 oz. and 32 oz. bags, manufactured by Rader Farms of Lynden, WA, because both products have the potential to be contaminated with Norovirus. Norovirus is a highly contagious virus. Typical symptoms of norovirus infection are acute onset of vomiting, watery, non-bloody diarrhea with abdominal cramps, and nausea. Systemic manifestations include, fever, myalgia and malaise, anorexia, and headache. Although most symptoms end within 48 hours, the elderly, young children and immunocompromised persons may develop prolonged or more severe symptoms.

WinCo Foods has removed the recalled products from store shelves.

Product was distributed to WinCo Foods stores in Arizona, California, Idaho, Montana, Nevada, Oklahoma, Oregon, Washington, Texas, and Utah.

THIS NOTICE AFFECTS THE FOLLOWING PRODUCTS (see attached labels). The Best By Code is located on the front of the package near the product image.

WINCO FOODS FROZEN BLACKBERRIES, 16 OZ. BAG – UPC: 70552-30502, Best By Code Dec/09/2021.

WINCO FOODS FROZEN BERRY MEDLEY, 16 OZ. BAG – UPC: 70552-30522, Best By Code Dec/09/2021.

WINCO FOODS FROZEN BERRY MEDLEY, 32 OZ. BAG – UPC: 70552-30512, Best By Code Dec/09/2021.

No customer illnesses have been reported to date. (more…)

Pero Family Farms Food Co. Issues Alert on Undeclared Egg and Milk Allergens in Zucchini Trays

Posted by jbushland on

Summary

Company Announcement Date:
March 11, 2020
FDA Publish Date:
March 11, 2020
Product Type:
Food & Beverages
Reason for Announcement:
Undeclared egg and milk
Company Name:
Pero Family Farms Food Company, LLC
Brand Name:
Pero Family Farms
Product Description:
Zucchini Spiral Pesto Side Dish Kit

Company Announcement

Pero Family Farms Food Company, LLC has initiated a voluntary product recall of its 11oz “Zucchini Spiral Pesto Side Dish Kit” with run number code 1196272F; Use By date of 03/20/2020 due to a product mislabeling which did not declare the allergens of egg and milk. People who have an allergy or severe sensitivity to these allergens run the risk of serious or life-threatening allergic reaction if they consume these products.

This product was processed by Pero Family Farms Food Company, LLC and distributed under the Pero Family Farms Label in Florida, Alabama, Tennessee, South Carolina, North Carolina, Virginia and Georgia. It is packaged in a flexible clear plastic container with labeling on the top and bottom. The product run number code and use by date can be found on the front bottom right hand corner of the package.

No illnesses have been reported to date in connection with this issue. (more…)

Meijer Recalls Select Mixed Nuts due to Undeclared Brazil Nuts in Product

Posted by jbushland on

Summary

Company Announcement Date:
March 09, 2020
FDA Publish Date:
March 10, 2020
Product Type:
Food & Beverages
Reason for Announcement:
Undeclared Brazil nuts
Company Name:
Meijer
Brand Name:
Meijer
Product Description:
Mixed Nuts

Company Announcement

Meijer is initiating a voluntary recall of 13,284 packages of mixed nuts due to the potential risk of an undeclared tree-nut allergen (Brazil nuts) sold at all Meijer stores, and is being issued to its customers in cooperation with the U.S. Food & Drug Administration. People who have an allergy or severe sensitivity to Brazil nuts run the risk of serious or life-threatening allergic reaction if they consume these products.

Meijer is recalling the following products sold in clear plastic 16 oz. packages under the Meijer brand label with the following sell-by dates:

  • UPC – 7-1928380863-9 – Fresh from Meijer – Mixed Nuts with Peanuts & Sea Salt – 16 oz.
  • Sell by dates: 7-16-2020, 9-5-2020, 10-15-2020

Customers who have purchased this product should throw it away or return the product to the nearest Meijer store for a full refund. Customers with questions regarding this recall should contact Meijer at 800-543-3704, available 24 hours a day, seven days a week. Customers with an allergy or sensitivity to Brazil nuts should not consume the recalled product. Customers with questions or concerns about their health should contact their physician.

The recall was initiated after it was discovered the product contained Brazil nuts, which is not part of the product formulation or declared on package labeling. Subsequent investigation revealed an incorrect formulation was used to manufacture this product and should not have included the Brazil nuts. The multi-state recall involves product potentially sold between Dec. 5, 2019 and March 9, 2020 in all Meijer super stores in Michigan, Ohio, Indiana, Illinois, Kentucky and Wisconsin. There have been no illnesses reported to date. (more…)

BD Provides Update on Feb. 4, 2020 Voluntary Recall of the BD Alaris™ System PC Units and Modules

Posted by jbushland on

Summary

Company Announcement Date:
March 09, 2020
FDA Publish Date:
March 10, 2020
Product Type:
Medical Devices
Reason for Announcement:
Infusion pump may not operate as expected
Company Name:
Becton, Dickinson, and Company
Brand Name:
BD Alaris
Product Description:
BD Alaris System PC Units and Modules

Company Announcement

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today provided an update on a previously announced voluntary recall of the BD Alaris™ System regarding software for the PC Unit and certain modules. BD has notified customers affected by this recall, and there is no change to those recall instructions.

This recall, which BD announced on Feb. 4, 2020External Link Disclaimer, has been designated as a Class I recall by the U.S. Food and Drug Administration (FDA) and has been associated with medical device reporting (MDR) submissions. (more…)

Voluntary Field Corrective Action of HiRes Ultra and Ultra 3D

Posted by jbushland on

Summary

Company Announcement Date:
February 20, 2020
FDA Publish Date:
March 10, 2020
Product Type:
Medical Devices
Reason for Announcement:
Reports of hearing performance degradation
Company Name:
Advanced Bionics
Brand Name:
HiRes Ultra and Ultra 3D
Product Description:
Cochlear implants

Company Announcement

Advanced Bionics (AB), a global leader in developing advanced cochlear implant systems, announced today that it has begun notifying regulatory authorities that it will voluntarily initiate a field corrective action related to the initial version of HiRes Ultra and Ultra 30 cochlear implant devices due to a decrease in performance experienced by a small percentage of recipients.

AB’s priority is to ensure that all cochlear implant recipients and health care providers have the information they need to understand this situation and that they receive the necessary support. Existing recipients of HiRes Ultra and Ultra 3D may continue to use their device as normal. If recipients experience issues of hearing degradation they should visit their audiologist or other health care provider. In addition, we will begin the notification process for device recipients worldwide, where allowed, to make them aware of the potential issue

This voluntary action is being taken in an abundance of caution in response to recent increases in Ultra device explants related to low impedances and reports of hearing performance degradation. As of February 11, 2020, of the more than 16,000 recipients of these implants, less than 0.5% have been explanted for this reason. Please note that this device-related issue may manifest in performance degradation that could require revision surgery. The only potential for patient harm are the risks associated with a surgery. (more…)

Sun Hong Foods, Inc. Recalls Enoki Mushroom Because of Possible Health Risk

Posted by jbushland on

Summary

Company Announcement Date:
March 09, 2020
FDA Publish Date:
March 09, 2020
Product Type:
Food & Beverages
Reason for Announcement:
Potential to be contaminated with Listeria monocytogenes
Company Name:
Sun Hong Foods, Inc.
Brand Name:
Sun Hong Foods
Product Description:
Enoki Mushrooms

Company Announcement

Sun Hong Foods, Inc 1105 W Olympic Blvd, Montebello, CA 90640 is recalling All Cases Enoki Mushroom (Product of Korea) Net Wt 7.05/200g because it has the potential to be contaminated with Listeria monocytogenes, a bacterium which can cause life-threatening illness or death. Consumers are warned not to even if it does not look or smell spoiled.

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.

Product was distributed (CA, TX, OR, WA, TX, IL, FL).

Stores that maybe carry our brand: (Asian Supermarket), J&L Supermarket, Jusgo Supermarket, ZTao Market, New Sang Supermraket, Galleria Market.

Enoki mushroom is packaged in a White Cardboard Box, inside has 25 count of 200g.

Enoki mushrooms are white, with long stems and small caps. They’re usually sold in clusters. The affected products are sold in clear plastic bags with green panels: labeling in front of packaging will have 4 characters in korea, Enoki Mushrooms (orange front), Product of Korea, Net weight 7.05 oz/200g.

  • UPC 7 426852 625810
  • Brand name in back: Sun Hong Foods, Inc
  • Packaging: 7.05 oz/200g
  • Sold under refrigerated conditions

Sun Hong Foods became aware of this issue after notification by FDA that samples of the product tested by the State of Michigan were found to be positive for Listeria monocytogenes.

We are aware that ill persons who may have consumed the product are under investigation. (more…)

Dole Fresh Vegetables, Inc. Announces Voluntary Limited Recall of H-E-B-branded Tuscan Herb Salad Kit Due to Undeclared Allergens

Posted by jbushland on

Summary

Company Announcement Date:
March 06, 2020
FDA Publish Date:
March 06, 2020
Product Type:
Food & Beverages
Reason for Announcement:
Undeclared peanut, wheat, soy & tree nuts
Company Name:
Dole Fresh Vegetables, Inc.
Brand Name:
HEB
Product Description:
Salad Kit, Tuscan Herb

Company Announcement

Dole Fresh Vegetables, Inc. is initiating a limited voluntary Recall of the following products:

Product Name and UPC Code on Packaging Best-By Date
H-E-B-branded Tuscan Herb Chopped Salad
0-41220-40989-1		 B055014 and B055015 MAR 11 2020

This recall is due to possible undeclared allergens (peanut, wheat, soy and tree nuts) in H-E-B-branded Tuscan Herb Salad Kit, which was manufactured by Dole for H-E-B. The incorrect masterpack (kit with dressing and other toppings) was unintentionally used during the production of the salad. No illnesses or allergic reactions have been reported, to date. However, people who have an allergy to peanut, wheat, soy and tree nuts may have a serious or life-threatening allergic reaction if they consume these products or products containing the allergens listed above. (more…)

Hikma Pharmaceuticals USA Inc. Extends Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP 30mg/mL, 1mL Fill/2mL Vials Due to the Potential Presence of Small Particulates

Posted by jbushland on

Summary

Company Announcement Date:
March 04, 2020
FDA Publish Date:
March 05, 2020
Product Type:
Drugs
Reason for Announcement:
Potential Presence of Small Particulates
Company Name:
Hikma Pharmaceuticals USA Inc.
Brand Name:
West-Ward
Product Description:
Ketorolac Tromethamine Injection, USP 30mg/mL, 1 mL Vial

Company Announcement

Hikma Pharmaceuticals PLC (Hikma, Group), today announces that its subsidiary Hikma Pharmaceuticals USA Inc. (formerly known as West-Ward Pharmaceuticals Corp.; “Hikma”) is voluntarily extending its previously-announced recall of certain lots (listed below) of Ketorolac Tromethamine Injection USP 30mg/mL, 1mL fill/2mL vials to the medical facility and retail levels. The product is being recalled due to the presence of small visible particulate matters of a gelatinous/oily nature that appear black in some of the recalled lots.

On December 23, 2019, Hikma voluntarily initiated a recall of this product to the direct customer level. In coordination with the U.S. Food and Drug Administration (FDA), Hikma is extending the recall to the medical facility and retail levels.

Administration of the affected product could potentially result in the deposition of particulates in the lungs of patients, which could result in multiple pulmonary microemboli with subsequent acute respiratory distress for patients receiving the drug intravenously.

Although Hikma has not received any reports of adverse events related to this issue, it is nonetheless extending its recall of these products out of an abundance of caution and to promote patient safety, which is Hikma’s highest priority. (more…)

Vita Food Products Issues Voluntary Recall of Mislabeled Vita Wild Herring Wine Sauce Containing Undeclared Milk

Posted by jbushland on

Summary

Company Announcement Date:
March 04, 2020
FDA Publish Date:
March 05, 2020
Product Type:
Food & Beverages
Reason for Announcement:
Undeclared Milk
Company Name:
Vita Food Products, Inc.
Brand Name:
Vita
Product Description:
Wild Herring In Wine Sauce

Company Announcement

Vita Food Products, Inc. of Chicago, Illinois is notifying the public that it is recalling up to 8,376 individual plastic jars of 32 ounce Vita Wild Herring in Wine Sauce that are potentially mislabeled because they may contain sour cream and, therefore, 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 this product. There have been no illnesses reported to date in connection with this product. (more…)