Category Archives: Salmonella

FDA

Image CDC

Salud Natural Entrepreneur, Inc. of Waukegan, IL is voluntarily recalling Nopalina Flax Seed Fiber (powder) and Nopalina Flax Seed Fiber (capsule) products due to possible Salmonella contamination in one of the ingredients used on the formula of Nopalina Flax Seed Fiber. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. Consumers of these products who are experiencing symptoms of Salmonella should contact their health care provider. To date, there are no reports of illnesses associated with the products.

Nopalina Flax Seed products are distributed throughout the United States and Puerto Rico via retail stores and the company’s web site https://www.nopalinaonline.com/External Link Disclaimer

The following lot numbers are affected by this recall (the lot numbers can be found on the bottom back of the product label):

Nopalina Flax Seed Fiber (powder, 1 lb. bags) UPC 890523000720

• Lot # 62.19 / 9 # 52.1 Best if used by 10/7/21
• Lot # 62.19 / 2 # 52.1 Best if used by 10/7/21

Nopalina Flax Seed Fiber (powder, 1 lb. bags) UPC 890523000720

• Lot # 64.19 / 3 # 52.1 Best if used by 10/21/21

Nopalina Flax Seed Fiber (powder, 1 lb. bags) UPC 890523000720

• Lot # 65.19 / 1 # 52.1 Best if used by 10/24/21
• Lot # 65.19 / 2 # 52.1 Best if used by 10/24/21

Nopalina Flax Seed Fiber (powder, 2 lb. bags) UPC:890523000843

• Lot # 64.19 / 2 # 52.1 Best if used by 10/21/21
• Lot # 64.19 / 2 * 2Lb # 52.1 Best if used by 10/21/21

Nopalina Flax Seed Fiber (capsules, 120 count) UPC 890523000867

• Lot # 23.19 1C120 # 07 Best if used by 10/7/21
• Lot # 23.192C120 # 02 Best if used by 10/7/21
• Lot # 23.19 / 2C120 # 02 Best if used by 10/7/21
• Lot # 23.19.2C120 # 02 Best if used by 10/7/21
• Lot # 23.19.3C120 # 02 Best if used by 10/7/21

This recall is being made with the knowledge of the Food and Drug Administration.

The recall is the result of an FDA sampling of senna leaves powder, an ingredient used to manufacture the Nopalina Flax Seed Fiber (powder) and Nopalina Flax Seed Fiber (capsules), that tested positive for three types of Salmonella including Salmonella Gaminara, Salmonella Kentucky, and Salmonella Oranienburg. The company has ceased the use of the suspect ingredient.

We care deeply about the health of all of our consumers and are committed to providing with safe and high quality products. Salud Natural Entrepreneur, Inc. has identified and isolated the ingredient to prevent this from happening again.

Consumers who have purchased Nopalina Flax Seed Powder and Nopalina Flax Seed Capsules having the lot numbers listed above should not consume them and are urged to return it to the place of purchase for a full refund.

Consumers with questions may contact the company at 877-296-6845 (Monday to Friday 9am-5pm) or can go to our site: https://www.nopalinaonline.com/certificate/External Link Disclaimer

Symptoms of salmonellosis

Salmonella are a group of bacteria that can cause gastrointestinal illness and fever called salmonellosis. Most people infected with Salmonella begin developing symptoms 12 to 72 hours after infection. The illness usually lasts four to seven days and most people recover without treatment.

Most people with salmonellosis develop diarrhea, fever, and abdominal cramps. More severe cases of salmonellosis may include a high fever, aches, headaches, lethargy, a rash, blood in the urine or stool, and in some cases may become fatal.

Children younger than five, the elderly, and people with weakened immune systems are more likely to have severe salmonellosis infections.

FDA

Audience

Consumers who have purchased Nopalina Flax Seed Fiber (powder) and Nopalina Flax Seed Fiber (capsules) manufactured by Salud Natural Entrepreneur, Inc. with the specific lot numbers listed below.

Products

Nopalina Flax Seed Fiber (powder) and Nopalina Flax Seed Fiber (capsules) with lot numbers (Product Image):

Nopalina Flax Seed Fiber (powder, 1 lb. bags)

• Lot # 62.19/9#52.1 Best if used by 10/7/21
• Lot # 62.19/2#52.1 Best if used by 10/7/21

Nopalina Flax Seed Fiber (powder, 1 lb. bags)

• Lot # 64.19/3#52.1 Best if used by 10/21/21

Nopalina Flax Seed Fiber (powder, 2 lb. bags)

• Lot # 64.19/2#52.1 Best if used by 10/21/21
• Lot # 64.19/2*2Lb#52.1  Best if used by 10/21/21

Nopalina Flax Seed Fiber (powder, 1 lb. bags)

• Lot # 65.19/1#52.1 Best if used by 10/24/21
• Lot # 65.19/2#52.1 Best if used by 10/24/21

Nopalina Flax Seed Fiber (capsules, 120 count)

• Lot # 23.19 1C120#07 Best if used by 10/7/21
• Lot # 23.192C120#02 Best if used by 10/7/21
• Lot # 23.19/2C120#02 Best if used by 10/7/21
• Lot # 23.19.2C120#02 Best if used by 10/7/21
• Lot # 23.19.3C120#02 Best if used by 10/7/21

The lot numbers can be found on the bottom back of the product label.

Purpose

The FDA is advising consumers to stop using Nopalina Flax Seed Fiber (powder) and Nopalina Flax Seed Fiber (capsules) identified by the lot numbers above due to possible Salmonella contamination. Consumers of these products who are experiencing symptoms of salmonellosis should contact their health care provider. To date, there are no reports of illnesses associated with the products.

Symptoms of salmonellosis

Salmonella are a group of bacteria that can cause gastrointestinal illness and fever called salmonellosis. Most people infected with Salmonella begin developing symptoms 12 to 72 hours after infection. The illness usually lasts four to seven days and most people recover without treatment.

Most people with salmonellosis develop diarrhea, fever, and abdominal cramps. More severe cases of salmonellosis may include a high fever, aches, headaches, lethargy, a rash, blood in the urine or stool, and in some cases may become fatal.
Children younger than five, the elderly, and people with weakened immune systems are more likely to have severe salmonellosis infections.

Summary of Problem and Scope

The FDA collected a product sample of senna leaves powder, an ingredient used to manufacture the Nopalina Flax Seed Fiber (powder) and Nopalina Flax Seed Fiber (capsules), that tested positive for three types of Salmonella including Salmonella Gaminara, Salmonella Kentucky, and Salmonella Oranienburg. The FDA notified the firm of the results. To date, we are not aware of illnesses linked to these products.

FDA Actions

The FDA intends to use all available tools to remove contaminated product from the market.

Recommendations for Consumers

Consumers who have these products should no longer use them. Consumers who have symptoms of salmonellosis should contact their health care provider to report their symptoms and receive care.

To report a complaint or adverse event (illness or serious allergic reaction), you can:

• Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.
• Report the adverse event to the FDA through the Safety Reporting Portal.

Visit www.fda.gov/fcic for additional consumer and industry assistance.

Additional Information

• FDA – Salmonella
• FoodSafety.gov – Salmonella
• CDC – Salmonella