The Recall Desk
HighFDA (Food)·F-2957-2015·Announced 2015-08-19

ASN Dietary Supplements Recalled for Unapproved Drug Claims

James G. Cole, Inc. is recalling all ASN brand products nationwide because they are misbranded, adulterated, and unapproved new drugs.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves unapproved new drugs and misbranded products, which presents a risk of harm, but the source text does not report any specific illnesses or injuries, aligning with the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

James G. Cole, Inc., doing business as ASN/Maxam Neutraceutics, is recalling all ASN brand products. The affected products are in capsule or powdered form and bear the ASN label. Specific products listed include Affinity Whey Protein, DHEA, Humagro Homeopathic Growth Hormone 4c, Phytobol, Testrx, and Tribestron II. The recall covers all lots and all best by dates.

The recall was ordered by the United States District Court for the District of Oregon. The products are also being recalled because they are considered misbranded, adulterated, and unapproved new drugs. This determination was made because certain claims about the products' effects had not been approved by the FDA.

The products were distributed nationwide. Consumers should stop using these products and follow the instructions provided by the recalling firm or the FDA.

The recalled product

Product
ALL ASN products: The ASN products are in capsule or powdered form and bear the ASN label. *********the List of ASN products***************************** AFINITY WHEY PROTEIN; DHEA; HUMAGRO Homeopathic Growth Hormone 4c; PHYTOBOL; TESTRX; TRIBESTRONE II;
Manufacturer
James G. Cole, Inc., dba ASN/Maxam Neutraceutics
Category
Drug — Dietary Supplements
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots and all best by dates

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by James G. Cole, Inc., dba ASN/Maxam Neutraceutics under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · James G. Cole, Inc., dba ASN/Maxam Neutraceutics

See all →

Same hazard · unapproved drug

See all →