Categories
FDA

ABH NATURE’S PRODUCTS, INC, ABH PHARMA, INC., and STOCKNUTRA.COM, INC. Issues Nationwide Recall

TAFC ClipBoard: One might think that a company that advertises RAW WHOLE FOOD IODINE from organic kelp in veggie capsules, NON-GMO, manufactured with GMP (good manufacturing practices) in the USA wouldn’t be in violation of Good Manufacturing Practices that go back to January 2013 up to November 2019.

What else can a consumer rely on when purchasing a product than the label on the product indicating that it is safe to consume?

How often do these labels stating compliance with Good Manufacturing Practices require an update? How do they qualify to use the GMP symbol on their labels in the first place?

And why would the recall need to get decided in the U.S. District Court for the Eastern District of New York?

And after all those years, who would know that if they did get sick, it was a result of ‘risk’ being introduced into these particular products?

Once again, we need to allocate more funds to assure what we consume is actually safe.


Summary

Company Announcement Date:

January 21, 2020

FDA Publish Date:

January 21, 2020

Product Type:

Dietary Supplements

Reason for Announcement:

Products are recalled because of violations of current good manufacturing practice regulations

Company Name:

ABH NATURE’S PRODUCTS, INC, ABH PHARMA, INC., and STOCKNUTRA.COM, INC.

Brand Name:

ABH Nature’s Products, ABH Pharma, Stocknutra.com, Inc.

Product Description:

Dietary supplement products


Company Announcement

This is to inform you that ABH NATURE’S PRODUCTS, INC, ABH PHARMA, INC., and STOCKNUTRA.COM, INC. (the “COMPANIES”) is conducting a nationwide recall of ALL lots of its dietary supplement products pursuant to a Consent Decree entered by the U.S. District Court for the Eastern District of New York. This recall applies to all dietary supplement products manufactured and sold between January 2013 – November 2019 and all lots of products are included in this recall.

These products are being recalled after an FDA inspection found significant violations of current good manufacturing practice regulations. Manufacturing practices that are not in adequate control represent the possibility of risk being introduced into the manufacturing process resulting in finished supplement products with decreased identity, purity, strength and composition.

To date, there have been no reported illnesses or injuries as a result of this situation.

The COMPANIES contract manufactured dietary supplements for other firms and did not sell products directly to consumers.

The COMPANIES are notifying its distributors and customers via email and is arranging for return of all recalled products. Wholesalers and distributors (direct customers of the COMPANIES) that have any dietary supplement products manufactured or packaged at the Edgewood, NY facility being recalled should contact a representative of the COMPANIES for instructions with regard to returning any remaining stock.

Distributors or Consumers with questions regarding this recall can contact a representative of the COMPANIES by phone at (866) 922-4669 or e-mail recall@abhnutra.com, Monday – Friday, 9:00am – 4:30pm, EST.

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

ABH is working to refine their customer list. It has been removed from their press release pending their revised submission.


Company Contact Information

Consumers:Jahirul Islam (866) 922-4669 recall@abhnutra.com

  • Content current as of:01/21/2020
  • Regulated Product(s)
    • Dietary Supplements





Categories
FDA NET NEWS

Basil From Mexico Is Likely Cause of Cyclospora Food Poisoning Outbreak

 

A food poisoning outbreak tied to 132 cyclospora illnesses in 11 states was likely caused by fresh basil imported from Mexico by Siga Logistics de RL de CV, the Food and Drug Administration announced late Thursday.

Four people have been hospitalized.

The investigation is ongoing, but the agency has requested a voluntary recall, and Siga Logistics has agreed. The FDA is working with the company to facilitate the recall.

Cyclospora is a parasite that spreads when people eat food (or drink water) that has come into contact with contaminated feces. Illnesses that are part of this outbreak have been reported in Connecticut, Florida, Georgia, Indiana, Massachusetts, Minnesota, New York, Ohio, Rhode Island, South Carolina, and Wisconsin. In Florida, Minnesota, New York, and Ohio, some people were exposed to cyclospora at restaurants. The FDA did not name the restaurants.

The FDA did not immediately respond to a request for comment and a receptionist at Siga Logistics said no one was available to comment right away.

What Consumers Should Do

Consumers should not use or eat any fresh basil imported by Siga Logistics, the FDA advised.

If you already bought fresh basil and can’t determine where it is from—or if you don’t know the importer but do know it came from Mexico—throw it away.  

Fresh, uncooked basil often shows up in salads or in pesto, and as whole or chopped leaves in many restaurant dishes. So avoid ordering dishes with basil at restaurants, and ask that basil not be used to garnish your dish, unless the restaurant can assure you the herb didn’t come from Siga Logistics.

If you had basil in your refrigerator that might have been contaminated, or if you have used basil in the past few months, do a thorough cleaning. Wash and sanitize affected areas of your refrigerator and countertops, as well as cutting boards and utensils, and be sure to wash your hands with soap and warm water when you’re done.

Symptoms of Cyclospora

Symptoms of cyclospora usually emerge about a week after being infected, and the illness can last anywhere from a few days to a month or more.

Symptoms usually include watery, sometimes explosive diarrhea. Many people with cyclospora also experience fatigue, loss of appetite, stomach cramps, bloating, and nausea. In some cases vomiting, body aches, and flu-like symptoms can occur. Sometimes cyclospora symptoms go away and then return, and some people with the infection do not experience symptoms at all.

The Details

Products recalled: There’s no formal recall yet, but the FDA is working with Siga Logistics de RL de CV to facilitate a recall of basil the company imported into the U.S. from Mexico.The problem: The FDA has determined that this basil is the likely source of a cyclospora outbreak that has caused 132 illnesses in 11 states.

The fix: Throw away potentially affected basil, even if you plan to cook with it, to be safe. And don’t eat fresh basil from Siga Logistics. If basil is from Mexico but you don’t have information on the supplier, don’t eat it. And if you don’t know where the basil came from at all, avoid it. The FDA will update its page on this outbreak with more information as it becomes available.

Who to contact: Call your healthcare provider if you think you might be experiencing symptoms of cyclospora. You can also contact the FDA using the links found toward the bottom of this page. Siga Logistics has not yet provided contact information for consumers.

Source: Basil From Mexico Is Likely Cause of Cyclospora Food Poisoning Outbreak