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.
Company Announcement Date:
January 21, 2020
FDA Publish Date:
January 21, 2020
Reason for Announcement:
Products are recalled because of violations of current good manufacturing practice regulations
ABH NATURE’S PRODUCTS, INC, ABH PHARMA, INC., and STOCKNUTRA.COM, INC.
ABH Nature’s Products, ABH Pharma, Stocknutra.com, Inc.
Dietary supplement products
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 email@example.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 firstname.lastname@example.org
- Content current as of:01/21/2020
- Regulated Product(s)
- Dietary Supplements