Sunset Natural Products Recalls Venocell Dietary Supplement Under Consent Decree
Sunset Natural Products Inc. is recalling Venocell dietary supplements pursuant to a consent decree requiring the destruction of products manufactured or distributed since April 2, 2014.
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. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when associated with significant regulatory actions like consent decrees prohibiting future marketing.
Plain-English summary
Sunset Natural Products Inc. is recalling Venocell dietary supplements, sold in bulk quantities of 50,000 capsules. The recall involves a total of 100,000 capsules with Lot # 160614 (Exp. Date 06/17) and Lot # 490914 (Exp. Date 10/17). The product was distributed in Florida and Nevada.
This 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 supplements 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 Venocell should stop using the product and contact Sunset Natural Products Inc. for further instructions. The FDA has classified this recall as Class II.
The recalled product
- Product
- Venocell, sold in bulk of 50,000 capsules.
- Manufacturer
- Sunset Natural Products Inc.
- Category
- Food — Dietary Supplement
- Affected units
- 100,000
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 # 160614 Exp. Date 06/17 and Lot # 490914 Exp. Date 10/17
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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