STATEMENT ON ABH PHARMA, INC. JANUARY 2020 RECALL

FDA Publish Date: January 21, 2020
Company Announcement Date: January 23, 2020

In light of a national recall of products made by ABH Nature's Products, Inc.; ABH Pharma, Inc.; and Stocknutra.com Inc., on January 21, 2020 for failing to meet current good manufacturing practice regulations over 800 companies were affected.

Since the release of the nationwide recall by ABH Nature’s Products, Inc., ABH Pharma, Inc. and Stocknutra.com, Inc. (collectively “ABH”), we have received a number of questions regarding whether we have done business with ABH. As we believe in total transparency, we want to provide you with the following information:

 

Has Biofinest Ever Worked with ABH?

We have had very limited contact with ABH over our 10+ year history. More specifically, the only work we have ever done with ABH is the bottling of the following lots of our product:

 

Product: BHB Salts Ketones (Raspberry Lemon)

Lot Number: # 0117197

Production Date: 4/2017 (Expired 04/19)

Discontinued Date: 4/2019

Batch Units: 1500
Procedure: Packaging, Labelling

Incidents/Injuries: None

 

No other Biofinest branded products were ever made by these companies or are part of this recall. We want to reassure you that our company has not manufactured or sold any of those businesses' products cited, with the exception of one limited co-packaging and labelling run above, which we have since discontinued.

 

What Products Are Affected?

BHB Salts Ketones (Raspberry Lemon) - Packaging and Labeling

 

Were These Lots of BHB Salts Ketones Manufactured At The ABH Facility?

No. To our knowledge, the above-referenced Lots of BHB Salts Ketones powders were manufactured by another supplier. ABH simply put the powders into bottles and applied labels to the bottles. We have made numerous attempts to obtain documentation from ABH to determine whether the bottling and labelling occurred at the non-compliant facility mentioned in the Consent Decree, but have yet to receive a response from ABH.

 

How Great Is The Risk?

To date, Biofinest has received NO COMPLAINTS and there have been NO INCIDENTS related to any lot number of BHB Products packaged at ABH.

 

Why Is This Recall Happening?

As per the FDA, (and news to many other 800+ Brands), ABH was not following GMP’s (Good Manufacturing Practices) in the production of Nutritional Supplements made in their facility.

 

What Safeguards Do We Use To Ensure Safety?

Being a tolling operation is one of the safeguards we use to ensure quality and safety. We know our Raw Material Suppliers by name, and visited their production facilities. Our relationship with many of them date back decades. Additionally, Biofinest sources and purchases all ingredients for our products. Knowing exactly where these ingredients are coming from allows us an additional layer of security in knowing what is going into our products. For this reason and many others, we believe our materials to be of the highest quality you can find today.

 

Have There Been Any Reports Of Contamination Of Illnesses?

No. To date there have been no reports of illness. You can rest assured that we triple test all of our raw materials, as well as our finished products, to ensure safety and purity.

 

How Often Does This Happen?

This is the first time in Biofinest's 10+ year history that we have a manufacturer recall. It came as quite a surprise to us given that all raw materials in the product had passed microbiological analyses and additional testing. In consultation with other companies in our industry, we have discovered that product recalls are more common than we suspected. Nearly all major dietary supplement companies who utilize plant materials have experienced one or more recalls.

 

What is GMP procedures?

GMP procedures require that every raw material ingredient designated for use in a dietary supplement be analysed for microbiological contamination. These procedures were followed by the raw material supplier. No contamination was found in any of the ingredients that went into our products, nor was contamination found in the finished products. You can see the list our co-manufacturing cGMP certificates HERE.

 

How Will We Prevent This From Occurring Again?

We have adjusted our Co-Manufacturing selection criteria to include a thorough look into the co-manufacturing history.

We have only worked with Co-manufacturers with robust quality management plan, includes quality control and quality assurance with top-quality international certifications.

We have altered our vetting process for Co-packers to include annual inquiries with the FDA to ascertain if any of our Co-Packers are in violation of GMP standards.

We have increased our auditing schedule from annual to semi-annual to ensure we have the most up-to-date information.

 

Where is Your Manufacturing Facility?

Our supplement co-manufacturers are in Utah and California, Unites States. With regularly inspected NSF cGMP certified facility that prioritize sanitation, safety, and product integrity, our state-of-the-art facility adheres to rigorous quality standards and practices, with more than 20 years of experience producing the highest quality nutritional supplements.

 

What Is Your Commitment to Customers?

To our valued customers, our commitment to provide you with the highest quality nutritional supplements using the latest technologies and the purest nutrients nature has to offer. With safety and efficacy being of the utmost importance, it’s our promise to continue to take great care in developing products you can trust with the quality you know and expect from Biofinest.

Focused on integrity, quality, and safety, our top priority will always be to provide our customers with superior, professional-grade supplements they can trust.