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

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** 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.)

Public Advisory Link

1928-Hundreds of Black Victims of Hurricane Denied Proper Burial in West Palm Beach, Florida



On September 16, 1928, a Category 4 hurricane with winds of 140 miles per hour made landfall in Palm Beach County, Florida. The hurricane destroyed a levee that protected a number of small, low-lying farming communities from the waters of Lake Okeechobee. Water from Lake Okeechobee rushed in when the levee was destroyed, killing thousands. Most residents in these areas were Black migrant farm workers.

Historical Marker

After the hurricane, Black survivors were forced to recover the bodies of those killed. The officials in charge of the recovery effort ordered that food would be provided only to those who worked, and some people who refused to work were shot.

The bodies of white storm victims were buried in coffins in local cemeteries, but local officials refused to provide coffins or proper burials for Black victims. Instead, their corpses were stacked in piles by the side of the roads, doused in fuel oil, and burned. Authorities bulldozed the bodies of 674 Black victims into a mass grave in West Palm Beach. The mass grave was not marked and the site was later sold for private industrial use—first used as a garbage dump, then a slaughterhouse, and then a sewage treatment plant.

calendar.eji.org

1893 Settlers race to own fertile land taken from the Cherokee … creating “Trail of Tears”


On September 16, 1893, the largest land run in history begins with more than 100,000 people pouring into the Cherokee Strip of Oklahoma to claim valuable land that had once belonged to Native Americans. With a single shot from a pistol the mad dash began, and land-hungry pioneers on horseback and in carriages raced forward to stake their claims to the best acres.

Ironically, not many years before that same land had once been considered worthless desert. Early explorers of Oklahoma believed that the territory was too arid and treeless for white settlement, but several suggested it might be the perfect place to resettle Native Americans, whose rich and fertile lands in the southeast were increasingly coveted by Americans. The U.S. government later took this advice and began removing eastern tribes like the Cherokee and Choctaw to Oklahoma Territory in 1817. No more eager than the whites to leave their green and well-watered lands for the arid plains, some Native Americans resisted and had to be removed by force-most tragically, the 4,000 Cherokee who died during the brutal overland march known appropriately as the “Trail of Tears.”

For the complete article … go to the link below

history.com

September 16 ~ History


1620 – The Mayflower departed from Plymouth, England. The ship arrived at Provincetown, MA, on November 21st and then at Plymouth, MA, on December 26th. There were 102 passengers on board.

1893 – The “Cherokee Strip” in Oklahoma was swarmed by hundreds of thousands of settlers aka white people

1990 – An eight-minute videotape of an address by U.S. President George H.W. Bush was shown on Iraqi television. The message warned that action of Saddam Hussein could plunge them into a war “against the world.”

1994 – Exxon Corporation was ordered by federal jury to pay $5 billion in punitive damages to the people harmed by the 1989 Exxon Valdez spill.

1994 – Two astronauts from the space shuttle Discovery went on the first untethered spacewalk in 10 years.