FDA Recalls Maxam Products for Unapproved Drug Claims
James G. Cole, Inc. is recalling all Maxam brand products nationwide because they are misbranded, adulterated, and unapproved new drugs.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the products are identified as unapproved new drugs, which aligns with the 'Severe' criteria for significant regulatory violations and potential health risks.
Plain-English summary
James G. Cole, Inc., doing business as ASN/Maxam Neutraceutics, is recalling all Maxam brand products. The recall covers all lots and all best-by dates and is distributed nationwide. The products are oral sprays used for various nutritional support claims.
The recall was ordered by the United States District Court for the District of Oregon. The products are considered misbranded, adulterated, and unapproved new drugs because certain claims about their effects had not been approved by the FDA.
Consumers should stop using these products. The source text does not specify a return address or refund process.
The recalled product
- Product
- ALL MAXAM PRODUCTS: The Maxam product is used orally in spray form and bears the Maxam label. ********The List of MAXAM products********************************************** AD Nutritional Support for a Positive Outlook; AFX Nutritional Support for Healthy Cellular…
- Manufacturer
- James G. Cole, Inc., dba ASN/Maxam Neutraceutics
- Category
- Drug — Unapproved New Drug
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
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