Edgewood, NY—A contract manufacturer doing business as ABH Nature’s Products, Inc., ABH Pharama, Inc., and Stocknutra.com, Inc. (“ABH”) announced 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. The massive recall includes all lots of all dietary supplement products manufactured and sold between January 2013 and November 2019.
On December 26, 2019, the U.S. Department of Justice announced that the U.S. District Court for the Eastern District of New York permanently enjoined ABH Nature’s Products, Inc., ABH Pharma, Inc., StockNutra.com, Inc., and the company owner, Mohammed Jahirul Islam, from distributing adulterated and misbranded dietary supplements in violation of the Federal Food, Drug, and Cosmetic Act. According to a press release, ABH and Islam were required to destroy dietary supplements in their possession, custody, or control, as well as to implement several consumer safety measures before resuming the manufacturing or distributing of dietary supplements. “Those measures include hiring an independent expert to inspect ABH’s facility and certify that the facility has corrected all deficiencies and implemented current good manufacturing practices,” the announcement says. “[The injunction] also mandates that the defendants engage a labeling expert to review their product labeling and certify that claims on their products comply with the law.”
As explained in an announcement posted on January 21, 2020, by FDA, the recall comes after an FDA inspection found significant violations of current good manufacturing practice regulations. The announcement explains: 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.
Regarding the recall, wholesalers and distributors that have supplements manufactured or packaged at the Edgewood facility are advised to contact a representative of the ABH for instructions. Contact information is available here.
Consumers are advised to check the list of over 800 companies that distributed the dietary supplements to determine if they have purchased a recalled product that needs to be returned or destroyed. The list can be downloaded here.
The announcement states, “To date, there have been no reported illnesses or injuries as a result of this situation.” But any adverse reactions or quality problems experienced with the use of the products should be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax (information is available here).
Maintaining Quality and Safety Standards
In WholeFoods Magazine’s 2020 Forecast, Len Monheit, CEO, Trust Transparency Center (TTC), identified low-quality products from contract manufacturers as a top concern for industry this year. “We’ve had an acknowledged black opaque box in the middle of our supply chains forever,” Monheit told WholeFoods. “It’s Contract Manufacturing and to a certain extent all contract services including analytical labs. While some of these service providers are world class with a focus on quality and sourcing, many are low barrier to entry operations that reverse engineer leading products at a fraction of the cost, taking every shortcut imaginable. Brands don’t know what they don’t know, especially Internet (entry) brands, don’t know the questions they should ask of these service providers and since they’re startups, the minimums are quite attractive. This is an industry Achilles heel, we saw it with curcumin and astaxanthin products that we at TTC tested, and it’s a huge concern.”
Contract manufacturers that WholeFoods Magazine spoke with earlier in 2019 also stressed the need for companies to be very careful in selecting contract manufacturing partners, highlighting the importance of working with companies that are FDA cGMP compliant. Read their insights and advice, including 15 Questions to Ask Potential Partners.