FDA/USDA september RECALLS -UPDATES FOR PREVIOUS MONTHS ~ SAFETY ALERTS~ 2021


** Committed to the quality of its products and out of an abundance of caution, SEVIROLI FOODS, INC, of Bellmawr, NJ is recalling H-E-B Jumbo Stuffed Shells – 22 oz due to potential presence of foreign material in product (Metal). Consumption of hard or sharp foreign material could cause physical injury. The affected products were distributed to H-E-B stores in Texas.

The issue was discovered on September 09, 2021, after H-E-B was notified of four customer complaints. All product related to this recall has been removed from H-E-B store shelves.

The following products, with the specific lot numbers, are subject to recall:

Item #UPC #Item DescriptionLot CodeSell by Date
796702041220771110HEB Jumbo Stuffed Shells – 22 oz2 120807/27/22

Code is located on the back of the back, upper left corner. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase for a full refund.

Customers with any questions or concerns may contact H-E-B Customer Service at 1-855-432-4438 Monday through Friday from 8 a.m. to 6 p.m. Central Standard Time. Anyone concerned about an injury or illness should contact a healthcare provider. Media questions please contact Valentino Lucio news@heb.com

** Espi’s Sausage and Tocino Co., a Seattle, Wash. establishment, is recalling approximately 2,048 pounds of frozen ready-to-eat chicken and pork hot dog products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The frozen ready-to-eat chicken and pork hot dog product was produced on May 19, 2021. The following products are subject to recall [view the labels here]:

  • 12-oz vacuum packed plastic packages containing “Argentina MIGHTY MEATY CHICKEN AND PORK HOTDOG JUMBO” and SELL BY 051922.

The products subject to recall bear establishment number “EST. P-17524” inside the USDA mark of inspection. These items were shipped to a distributor in California and further distributed to retail locations.

The problem was discovered by FSIS during an assessment of the establishment’s sampling records that indicated the firm received confirmation from their third-party lab that a product contact surface had returned positive for Listeria monocytogenes.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.  

Consumption of food contaminated with L. monocytogenes can cause listeriosis, a serious infection that primarily affects older adults, persons with weakened immune systems, and pregnant women and their newborns. Less commonly, persons outside these risk groups are affected.

Listeriosis can cause fever, muscle aches, headache, stiff neck, confusion, loss of balance and convulsions sometimes preceded by diarrhea or other gastrointestinal symptoms. An invasive infection spreads beyond the gastrointestinal tract. In pregnant women, the infection can cause miscarriages, stillbirths, premature delivery or life-threatening infection of the newborn. In addition, serious and sometimes fatal infections in older adults and persons with weakened immune systems. Listeriosis is treated with antibiotics. Persons in the higher-risk categories who experience flu-like symptoms within two months after eating contaminated food should seek medical care and tell the health care provider about eating the contaminated food.

FSIS is concerned that some product may be in consumers’ freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.

FSIS advises those at increased risk of foodborne illness to reheat hot dogs to a minimum internal temperature of 165°F or until steaming hot before eating, due to the threat of listeriosis. The only way to confirm that hot dogs are cooked to a temperature high enough to kill harmful bacteria is to use a food thermometer that measures internal temperature, https://www.fsis.usda.gov/safetempchart.

Media and consumers with questions regarding the recall can contact Ester Somintac, Plant Manager for Espi’s Sausage and Tocino Co., at (206) 722-3365 or espisfood@yahoo.com.

** Eli Lilly and Company (NYSE: LLY) is voluntarily recalling lot D239382D, Expiration April 2022, of Glucagon Emergency Kit for Low Blood Sugar (Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe), to the consumer/user level. Lilly is recalling lot D239382D to the patient level because of a product complaint reporting that the vial of Glucagon was in liquid form instead of the powder form. The firm’s investigation indicates that the liquid in this Glucagon vial could be related to the manufacturing process. The use of the liquid form of this product may fail to treat severe low blood sugar due to loss of potency.

Risk Statement: Severe hypoglycemia in patients with diabetes, if not reversed, can potentially cause adverse health consequences ranging from transient, minor complaints to neurological damage, seizures, and even death if not promptly treated. Associated with the one product complaint, it was reported to Lilly that the involved patient experienced lack of drug effect and also reported subsequent seizures.

Glucagon Emergency Kit is used as an anti-hypoglycemic agent and a gastrointestinal motility inhibitor indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes mellitus.

The product is packaged in a kit containing 1mg of freeze-dried (lyophilized) product in a 3 mL vial and a pre-filled diluent syringe. The affected Glucagon Emergency Kit lot is D239382D and the expiration date is April 2022 (label expiry date: 04 2022). The lot number can be found on the

label of the kit as well as the vial (refer to the photos provided below – Appendix A). The lot was distributed nationwide to wholesalers and retailers.

Lilly is deeply committed to manufacturing high-quality medicines for patients who need them, and the safety and quality of our products is our highest priority. We take our obligations seriously and have rigorous quality systems in place to ensure compliance with stringent regulatory requirements.

Lilly is notifying its distributors and customers by written communication and is arranging for return and replacement of all recalled products. Wholesalers and Distributors with an existing inventory of Glucagon Emergency Kit lot D239382D should cease distribution and quarantine the product immediately.

Instructions for Wholesalers and Pharmacists

If you have distributed the recalled product, please notify any accounts or additional locations which may have received product from the recalled lot from you. Please conduct a sub-recall to those accounts and communicate this recall information immediately. Please request they immediately cease distribution of the product and promptly contact Sedgwick at 877-907-7032 (Interactive Voice Recording), 877-884-9410 (Fax), or elililly7484@sedgwick.com (Mon.-Fri. 8:00 am – 5:00 pm ET) to obtain a Business Reply Card (BRC) to initiate the return process.

** Committed to the quality of its products and out of an abundance of caution, SEVIROLI FOODS, INC, of Bellmawr, NJ is recalling H-E-B Jumbo Stuffed Shells – 22 oz due to potential presence of foreign material in product (Metal). Consumption of hard or sharp foreign material could cause physical injury. The affected products were distributed to H-E-B stores in Texas.

The issue was discovered on September 09, 2021, after H-E-B was notified of four customer complaints. All product related to this recall has been removed from H-E-B store shelves.

The following products, with the specific lot numbers, are subject to recall:

Item #UPC #Item DescriptionLot CodeSell by Date
796702041220771110HEB Jumbo Stuffed Shells – 22 oz2 120807/27/22

Code is located on the back of the back, upper left corner. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase for a full refund.

Customers with any questions or concerns may contact H-E-B Customer Service at 1-855-432-4438 Monday through Friday from 8 a.m. to 6 p.m. Central Standard Time. Anyone concerned about an injury or illness should contact a healthcare provider. Media questions please contact Valentino Lucio news@heb.com

** Monterey, California – September 10, 2021 – Dole Fresh Vegetables, Inc.  is voluntarily recalling a limited number of cases of conventional Curly Leaf Parsley. The product being recalled is Dole® Curly Leaf Parsley, with harvest dates of August 18, 2021, and August 19, 2021.  A random, routine regulatory sample collected in Michigan tested positive for non-O157 STEC (Shigatoxin-producing E. coli). Dole Fresh Vegetables is coordinating closely with regulatory officials in connection with the Recall; no illnesses have been reported. 

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 product was distributed to retail stores, wholesalers, and distributors in two pack sizes – 60-count (74 cases) and 30-count (39 cases). Retailers, wholesalers, and distributors can find the product code in the lower right portion of the PTI label.  The product code for both the 60 count cases and the 30 count cases is 0 07143 000310 3.  Individual bunches of parsley purchased by consumers have a price look-up (PLU) number on binding twist-ties of 4899 and a UPC code of 0 3383 80330 0. The Curly Leaf Parsley subject to this Recall was distributed in FL, IA, MI, MN, and MO.

This precautionary recall is being initiated due to a positive non-O157 STEC result found on a single sample collected by the Michigan Department of Agriculture during routine random sampling.

Only conventional Curly Leaf Parsley harvested on the dates noted above bearing the specific PLU and UPC code found on the bunches and PTI label codes found on the cases are included in this Recall.  No other Curly Leaf Parsley items are included in the Recall.  Consumers who have any product with these UPC/PLU Product Codes should not consume it, but rather discard it. Retailers and consumers with questions may call the Dole Consumer Center  at 1-800-356-3111, which is open Monday-Friday 8am-3pm PST.

** 030-2021Fratelli Beretta USA, Inc. Recalls Ready-to-Eat Uncured Antipasto Meat Products Due to Possible Salmonella Contamination (Aug 27, 2021)

** Green Field Farms Dairy of Fredericksburg, Ohio announces a voluntary recall of its Whole Chocolate Milk product, with a code date of 9/29/21, due to a laboratory analysis that indicated this product was not effectively pasteurized.

1,242 units of the affected product were distributed in Ohio, Indiana, Kentucky, Maryland, New Jersey, New York, Pennsylvania, Virginia, Delaware and Washington DC from September 7 through September 16, 2021. This quality issue is isolated to Whole Chocolate Milk with an expiration date of September 29, 2021.

The issue was discovered during routine product testing conducted by the Ohio Department of Agriculture. There have been no reports of illness involving products addressed in this recall, however, individuals exhibiting signs or symptoms of foodborne illness after consuming Green Field Farms Whole Chocolate Milk with an expiration date of September 29th should contact a physician immediately.

If you have purchased this product, please return to the place of purchase to receive a refund. Consumers with questions may call 330-263-0248.

**Pfizer is voluntarily recalling all lots of Chantix 0.5 mg and 1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit. As alternative suppliers have been approved in the United States, Pfizer is undertaking this precautionary measure.

Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication. The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.

Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.i

Chantix is a treatment to help patients quit smoking and is intended for short term use. People who smoke cigarettes are 15 to 30 times more likely to get lung cancer than people who do not smoke.ii

Smoking is also associated with many other cancers, as well as with cardiovascular disease and lung disease.iii CHANTIX has a safety profile that has been established over 15 years of marketing authorization and through a robust clinical program. Pfizer believes the benefit/risk profile of CHANTIX remains positive. Patients currently taking Chantix should consult with their healthcare provider about alternative treatment options. To date, Pfizer has not received reports of adverse events assessed to be related to this recall.

The NDC, Lot Number, Expiration Date, and Configuration details for Chantix Tablets are indicated in Appendix A. Photos of the products can be found in Appendix B. The products were distributed nationwide to Wholesalers and Distributors in the United States, US Virgin Islands and Puerto Rico from May 2019 to September 2021.

Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified their direct consignees by letter to arrange for return of any recalled product.

Wholesalers and Distributors with an existing inventory of Chantix tablets, should stop use and distribution and quarantine the product immediately.

If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Please conduct a sub-recall to those accounts and communicate this recall information immediately. Please request they immediately cease distribution of the product and promptly contact Stericycle at 888-276-6166 (Mon.-Fri. 8:00 am – 5:00 pm ET) to obtain a Business Reply Form (BRF) to initiate the return process.

If you received free product through the Pfizer Patient Assistance Program (PAP) or the Pfizer Institutional Patient Assistance Program (IPAP), please check your stock immediately. If you have any of the product in inventory, please follow the instructions above for returning the product to Stericycle Inc. Additionally, if you are aware of any patients to whom you dispensed the products and who still may have the product in their possession, please ask them to return the product to you and then follow the instructions above for returning the product to Stericycle Inc. For any questions related to Pfizer PAP or Pfizer IPAP product, please contact 833-203-2776 (Mon.-Fri. 8:00 am – 6:00 pm ET).

As communicated by FDA, there is no immediate risk to patients taking Chantix.iv Patients who are taking this product should consult with their health care provider to determine if alternate treatments are available. Patients with Chantix Tablets should contact Stericycle Inc. at 888-276-6166 (Mon.-Fri. 8:00 am – 5:00 pm ET) for instructions on how to return their product and obtain reimbursement for their cost.

Healthcare Professionals with questions regarding this recall can contact Pfizer using the below information.

Contact CenterContact InformationArea of Support
Pfizer Medical Information800-438-1985, option 3 (Mon.-Fri. 9 am-5 pm ET)
www.pfizermedinfo.comExternal Link Disclaimer
For medical questions regarding the product
Pfizer Drug Safety800-438-1985, option 1 (24 hours a day; 7 days a week)To report adverse events and product complaints

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being executed with the knowledge of the U.S. Food and Drug Administration.

Appendix A: Recalled Product Details

PRODUCT: Chantix Tablets, 0.5 mg NDC: 0069-0468-56
SIZE: Bottle of 56 Tablets
EXPIRATION DATE: January 2022 – May 2023
LOT NUMERS:

00019213DM9007EC6994EN8362
CY6861DM9008EN5725EN8467

PRODUCT: Chantix Tablets, 1 mg NDC: 0069-0469-56
SIZE: Bottle of 56 Tablets
EXPIRATION DATE: September 2021 – December 2023
LOT NUMBERS:

0001877700021024CW1572DF5280DY7987EN5694
0001928900021073CW1573DF5281EA6080EN5695
0001959300021074CW1574DF5282EC9841EP1717
00019682CW1565CW1575DR5086EC9842EP1718
00019846CW1566CW1578DR5092EC9843EP1719
00019977CW1567CW1579DR5093EC9847EW2012
00020295CW1568CW1581DR5094EC9848EW3854
00020448CW1569DF5277DT3885EE1011EW3865
00020458CW1570DF5278DW4148EM1069EX2102
00020480CW1571DF5279DW4152EM1070EX2103

PRODUCT: Chantix Tablets, 1 mg NDC: 0069-0469-03
SIZE: Carton containing 4 blister packs of 14 tablets each
EXPIRATION DATE: September 2021 – June 2023
LOT NUMBERS:

000194310002142100022765DR2614DY7060EE9391
000195420002142200022766DX4576DY9367EF2346
000195430002142300023134DX5870DY9473EM4805
000195440002213600023135DX5871DY9475EM4807
000208140002217400023747DX5872DY9476EN2005
000208150002217500023748DX5873DY9505ET1601
0002090700022176DL3896DX7805EC5910ET1605
0002096500022177DL7779DY6078EC5913ET1606

PRODUCT: Chantix Tablets, 0.5/1 mg NDC: 0069-0471-03
SIZE: Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg tablets
EXPIRATION DATE: August 2021 – January 2023
LOT NUMBERS:

00018522000203580002168800022851DM0277ET1607
00018523000207160002178800023136DY4470ET1609
00018739000208130002178900023137EC5911ET1611
00018740000212880002179000023190EC5912 
00020231000212890002179100023448ED6814 
000202320002142000021792DM0275ET1600 
000203570002168700022819DM0276ET1603 

References:

ihttps://www.fda.gov/drugs/drug-safety-and- availability/information-about-nitrosamine-impurities-medications

ii U.S. Centers for Disease Control and Prevention. What Are the Risk Factors for Lung Cancer?
https://www.cdc.gov/cancer/lung/basic_info/risk_factors.htm
Updated September 2020. Accessed June 2021.

iii U.S. Department of Health and Human Services. Smoking Cessation. A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2020.

** Drew’s Organics, LLC of Chester, VT is voluntarily recalling one lot code of Aldi Simply Nature Organic Poppy Seed Dressing due to a processing issue that could allow for microbial growth

The recalled product comes in a 12 fl. oz. glass bottle with the Best if Used By date of Feb 15 2023, and UPC #4099100023169.  The lot code is printed on the shoulder of the bottle above the label.

This action is being taken in cooperation with the US FDA.  Product has been distributed to select Aldi stores between August 20th and September 10th in the following states Alabama, Arizona, California, Connecticut, Delaware, Georgia, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, North Dakota, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Virginia, Vermont, Wisconsin, and West Virginia.

To date, no illnesses related to this product have been reported.  No other Aldi products are affected by this recall.

The recall was initiated after Drew’s Organics, LLC observed a color difference in the Simply Nature Organic Poppy Seed Dressing after manufacturing.  Investigation revealed out of spec pH with the potential for microbial growth, including Clostridium botulinum, rendering it unsafe for consumption.

Consumers should discontinue use of this product and can return it to their place of purchase for a full refund.

For more information, please contact Drew’s Organics, LLC between 8:30AM-4:30PM EST Monday-Friday at 1-800-228-2980 or email info@drewsorganics.com.

** The Kroger Co. (NYSE: KR) is voluntarily recalling its 16-ounce Kroger bagged kale product, produced by Baker Farms, due to possible listeria monocytogenes contamination.

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 infection can cause miscarriages and stillbirths among pregnant women. To date, we have not received any reports of illness related to the consumption of this bagged kale product.

This voluntary recall includes 16-ounce bags of Kroger branded Kale (see picture below), with the UPC 11110-18170 with a best by date of 09-18-2021, which is printed on the front of the package below the light blue bar.

All affected products were pulled from our Produce departments on Sept. 16, 2021.

The products were distributed by Kroger grocery stores in the Columbus, Nashville and Atlanta Divisions, servicing Columbus and Toledo, Ohio; Knoxville, Tennessee; eastern West Virginia; and the states of Georgia, Alabama and South Carolina.

Customers who have purchased the affected product are urged to dispose of it or return it to their local store for a full refund.

Customers who have questions may contact Kroger at 1-800-KROGERS Monday through Friday, 8:00 AM to 12:00 AM EST, and Saturday and Sunday, 8:00 AM to 9:30 PM EST.

** Plainsboro, New Jersey, Jacobus Pharmaceutical Company Inc. is voluntarily recalling 3 lots of Ruzurgi® (amifampridine) 10 mg tablets to the consumer level. The products have been found to be contaminated with yeast, mold, and aerobic bacteria based on laboratory test results.

Oral products heavily contaminated with yeast, mold, and aerobic bacteria may result in serious and life-threatening infections. The use of the defective product in patients with underlying immunosuppressive conditions such as Lambert Eaton Syndrome (LEMS) increases the concern for serious infections.

The product is used as a treatment for LEMS in patients ages 6 to less than 17 and is packaged in 100 count bottles (NDC: 49938-110-01). The affected Ruzurgi® (amifampridine) tablets lots include the following control numbers and expiration dates:

Control Number 18038, Expiration 03/2023

Control Number 18039, Expiration 03/2023

Control Number 18079, Expiration 05/2023

The Control Number is located to the right of the bottle’s front panel below the D2 Barcode.

Ruzurgi® (amifampridine) was distributed worldwide to specialty pharmacies and physicians.

Jacobus was informed of this issue by their Canadian partner that was conducting confirmatory full testing on Control Number 18038. Jacobus conducted an expanded investigation which identified Control Numbers 18039 and 18079.

Control Number 18038 was distributed between 05/25/2021 – 08/26/2021 (Canada only)
Control Number 18039 was distributed between 06/01/2021 – 08/10/2021
Control Number 18079 was distributed between 08/10/2021 – 08/30/2021

Jacobus Pharmaceutical Company Inc is notifying its distributors and customers via regular mail and electronic mail and is arranging for return of all recalled products. Consumers that have Ruzurgi® (amifampridine) which is being recalled should stop using and return this product.

If shipping via US Postal Service ship to:
Jacobus Pharmaceutical Company, Inc.
P.O. Box 5290, Princeton, NJ 08540.

If shipping via courier service (i.e., UPS, FedEx, etc.) ship to:
Jacobus Pharmaceutical Company, Inc.
IRL Building
31 Schalks Crossing Road
Plainsboro, NJ 08356.

Consumers with questions regarding this recall can contact Jacobus Pharmaceutical Company Inc. by phone at (609)799-8221 ext. 2120, Monday thru Friday from 9:00 AM to 5:00 PM Eastern Standard Time.

** Monterey, California – September 10, 2021 – Dole Fresh Vegetables, Inc.  is voluntarily recalling a limited number of cases of conventional Curly Leaf Parsley. The product being recalled is Dole® Curly Leaf Parsley, with harvest dates of August 18, 2021, and August 19, 2021.  A random, routine regulatory sample collected in Michigan tested positive for non-O157 STEC (Shigatoxin-producing E. coli). Dole Fresh Vegetables is coordinating closely with regulatory officials in connection with the Recall; no illnesses have been reported. 

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 product was distributed to retail stores, wholesalers, and distributors in two pack sizes – 60-count (74 cases) and 30-count (39 cases). Retailers, wholesalers, and distributors can find the product code in the lower right portion of the PTI label.  The product code for both the 60 count cases and the 30 count cases is 0 07143 000310 3.  Individual bunches of parsley purchased by consumers have a price look-up (PLU) number on binding twist-ties of 4899 and a UPC code of 0 3383 80330 0. The Curly Leaf Parsley subject to this Recall was distributed in FL, IA, MI, MN, and MO.

This precautionary recall is being initiated due to a positive non-O157 STEC result found on a single sample collected by the Michigan Department of Agriculture during routine random sampling.

** 026-2021, Greater Omaha Packing Recalls Raw Beef Products Due to Possible E. Coli O157:H7 Contamination (Jul 29, 2021)

** 028-2021, Serenade Foods Recalls Frozen Raw Breaded Stuffed Chicken Products due to Possible Salmonella Enteritidis Contamination (Aug 10, 2021)

** Fratelli Beretta USA, Inc., a Mount Olive, N.J. establishment, is recalling approximately 862,000 pounds of uncured antipasto products that may be contaminated with Salmonella Infantis and/or Salmonella Typhimurium, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The ready-to-eat (RTE) uncured antipasto meat trays were produced on February 28, 2021 through August 15, 2021. The following products are subject to recall [view labels]:   

  • 24-oz. trays containing two 12-oz packages of “Fratelli Beretta UNCURED ANTIPASTO PROSCIUTTO, SOPPRESSATA, MILANO SALAMI & COPPA” with best by dates of AUG 27 21 through FEB 11 22 and UPC code 073541305316.

The products subject to recall bear establishment number “EST. 7543B” printed on the packaging next to the best by date. These items were shipped to retail locations nationwide.     

Consumers with questions regarding the recall can contact Fratelli Beretta USA Inc.’s recall hotline at 1-866-918-8738. Media may contact Marco Lastrico of Barabino & Partners USA, at m.lastrico@barabinousa.com or 917-634-1685.

** On August 4, 2021, Cardinal Health (NYSE: CAH) initiated a nationwide recall of approximately 267 million MonojectTM Flush Prefilled Saline Syringes (0.9% Sodium Chloride). The products have been found to reintroduce air into the syringe after the air has been expelled. This could result in injection of air into blood vessels and create the potential for air embolism, which can cause serious adverse health outcomes or death.

Customers who have affected product(s) should immediately review their inventory and quarantine and return all affected product. The recall applies to all lots of the products manufactured from July 2019 to June 2021 distributed between July 2019 and July 2021.

The following SKUs have been recalled:

Name of ProductSKUs
12mL Syringe, 10 mL Saline Fill8881570121
12mL Syringe, 3 mL Saline Fill8881570123
12mL Syringe, 5 mL Saline Fill8881570125

Our Monoject™ 3mL syringe, 2.5mL Saline Fill is not affected by this recall. This item, SKU 8881570300, will be available for sale until inventory is depleted.

MonojectTM Flush Prefilled Saline Syringes can be identified by the barrel of the syringe, the case and the box as shown in the pictures below:

The company has received 37 reports of the plunger pulling back. No injuries have been reported to date.Cardinal Health voluntarily recalled MonojectTM Flush Prefilled Saline Syringes after learning that there is potential for the syringe’s plunger to draw back and reintroduce air back into the syringe. Cardinal Health has notified the U.S. Food and Drug Administration of this action.

Cardinal Health notified its distributors and customers by overnight delivery of a notification packet on August 5, 2021 and is arranging for return of all recalled products.

Cardinal Health distributes this product nationwide.

Customers with questions may contact the market action team via telephone at 800-292- 9332 between the hours of 8 a.m. – 5 p.m. EST. Customers may also contact the team

** Loki Fish Company of Seattle, Washington is recalling 4 oz. packages of Keta Salmon Lox (UPC code 92103 00111) 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 compromised 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 Keta Salmon Lox is packaged in a 4 oz. plastic package on a coated board. It is labeled as Wild Keta Lox, Loki Fish Co., Seattle, WA. There are no best by dates on the package.

The Keta Salmon Lox was distributed through Cherry Sprout Produce in Portland, OR and Central Co-op and Pacific Coast Harvest in Seattle, WA. It was also sold at the University District and West Seattle Farmers Markets in WA.

No illnesses have been reported to date.

The possibility of contamination was discovered during the FDA inspection at our co-packer Felix Custom Smoking, of Monroe, Washington in July 2021. Loki submitted samples of the Keta Lox to Micro-Chem Laboratories for testing. Loki has ceased production, sales, and distribution of keta lox immediately and Loki will continue the investigation as to what caused the problem.

If you have purchased this product, please do not consume it, and get rid of it immediately. You can return it to your place of purchase or to Loki Fish Company at the farmers market for a full refund. Consumers with questions may contact Hing Ng at Loki Fish Company (hing@lokifish.com; 206-937-1048, Monday-Friday, 8:30 a.m. to 5:00 p.m.)

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