Sunset Natural Products Recalls Prostamax DUO Dietary Supplement
Sunset Natural Products Inc. is recalling 4,000 bottles of Prostamax DUO dietary supplements in Florida and Nevada pursuant to a consent decree.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is driven by a consent decree and regulatory compliance issues rather than reported illnesses or specific product defects, fitting the criteria for a voluntary precautionary recall or minor labeling/compliance error.
Plain-English summary
Sunset Natural Products Inc. is recalling 4,000 bottles of Prostamax DUO, 60 capsules per bottle, in Florida and Nevada. The recall involves Lot # 140515 with an expiration date of 05/18 and UPC 850993004055.
The recall is being conducted pursuant to a consent decree that prohibits the company and its owners from marketing dietary supplements until they recall and destroy the products manufactured or distributed since April 2, 2014. The decree also requires the company to hire a cGMP expert and receive written permission from the FDA to resume operations.
Consumers who have purchased this product should stop using it and contact the recalling firm for instructions on disposal or return.
The recalled product
- Product
- Prostamax DUO, 60 capsules per bottle. Manufactured by Sunset Natural Products
- Manufacturer
- Sunset Natural Products Inc.
- Category
- Food — Dietary Supplement
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)
- Lot # 140515 Exp. Date 05/18 UPC 850993004055
Distribution
Part of a larger recall action
This product is one of 10 recalled by Sunset Natural Products Inc. 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.
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