The Recall Desk
SevereFDA (Food)·F-1003-2017·Announced 2017-01-04

Sunset Natural Products Recalls Venocell Bulk Capsules Under Consent Decree

Sunset Natural Products Inc. is recalling Venocell bulk capsules pursuant to a consent decree requiring the destruction of dietary supplements manufactured or distributed since April 2014.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the mandatory nature of the recall under a consent decree.

Plain-English summary

Sunset Natural Products Inc. is recalling Venocell, bulk capsules, pursuant to a consent decree with the U.S. Food and Drug Administration. The recall involves 100,000 capsules distributed to Florida, Nevada, and the Dominican Republic. Known lots include Lot # 370414 and Lot # 510414, both with an expiration date of 04/17.

The recall is mandated by a consent decree that prohibits the company and its owners from marketing dietary supplements until they recall and destroy all dietary supplements manufactured, prepared, processed, packed, labeled, held, and/or distributed between April 2, 2014, and the date of the decree's entry on September 25, 2015. The decree also requires the firm to hire a cGMP expert and receive written permission from the FDA to resume operations.

Consumers who have purchased Venocell bulk capsules should stop using the product and contact Sunset Natural Products Inc. for further instructions on disposal or return.

The recalled product

Product
Venocell, bulk capsules
Manufacturer
Sunset Natural Products Inc.
Category
Food — Dietary Supplements
Hazard
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 (12)

  • As persuant to the Consent Decree
  • the firm agreed to "recall and destroy
  • under FDA's supervision
  • in accordance with the procedures provided in paragraph 6
  • ALL dietary supplements that were manufactured
  • prepared
  • processed
  • packed
  • labeled
  • held and/or distributed between April 2
  • 2015. Known lots and expiration dates: Lot # 370414 Exp. Date 04/17
  • Lot # 510414 Exp. Date 04/17

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 163 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.

See all 163 products in this recall →

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