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

Consumers should check the attached list of companies who distributed the dietary supplements to determine if they have purchased a recalled product that needs to be returned or destroyed.

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

On December 26, 2019, the U.S. District Court for the Eastern District of New York ordered supplement manufacturers ABH Nature's Products, Inc., ABH Pharma, Inc., and StockNutra.com, Inc. (collectively known as ABH) and their owner, Mohammed Jahirul Islam, to stop distributing their products and destroy any products still in their possession. The decision follows a complaint filed by the FDA that charged the companies of serious manufacturing violations, including failure to verify that certain dietary supplements met product specifications for identity, purity, strength, and composition and failure to implement a production system that ensured the quality of supplements. The FDA also found that some of the companies’ products were misbranded as “new drugs” because their labels indicated they could treat medical conditions such as cancer and heart disease.

The court injunction bars the companies and their owner from manufacturing or distributing supplements until certain steps are taken, including hiring an independent expert to inspect facilities and certify that all current good manufacturing practices (cGMPs) are being followed and hiring a labeling expert to ensure that product labels comply with the law.

In a news release about the injunction, U.S. Attorney for the Eastern District of New York Richard P. Donoghue stated, “As demonstrated by today's consent decree, this office and the FDA will work tirelessly to protect consumers who take dietary supplements, ensuring that manufacturers comply with good manufacturing practices and do not distribute unapproved and misbranded drugs in violation of the Food, Drug, and Cosmetic Act.”

https://www.consumerlab.com/m/recall_detail.asp?recallid=14328

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