The Recall Desk
SevereFDA (Food)·F-0965-2017·Announced 2017-01-04

Sunset Natural Products Recalls True Vital Dietary Supplement Under Consent Decree

Sunset Natural Products Inc. is recalling True Vital dietary supplements pursuant to a consent decree requiring the destruction of products manufactured 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 (score 4) in the rubric, particularly given the context of a consent decree requiring destruction of products due to cGMP violations.

Plain-English summary

Sunset Natural Products Inc. is recalling True Vital, 30 capsules per bottle, pursuant to a consent decree with the U.S. Food and Drug Administration. The decree prohibits the company and its owners from marketing dietary supplements until they recall and destroy all products 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 company must also hire a cGMP expert and receive written permission from the FDA to resume operations.

The recall covers 1,000 bottles (30,000 capsules) of True Vital. The source text identifies a known lot number 130615 with an expiration date of 03/18. The products were distributed to Florida, Nevada, and the Dominican Republic.

Consumers who have purchased this product should stop using it and follow the instructions provided by the recalling firm or the FDA regarding the destruction of the product under FDA supervision.

The recalled product

Product
True Vital, 30 capsules per bottle
Manufacturer
Sunset Natural Products Inc.
Category
Food — Dietary Supplement
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 (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 lot and expiration date: Lot # 130615
  • 240215 Exp. Date 03/18

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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