The Recall Desk
SevereFDA (Food)·F-1077-2017·Announced 2017-01-04

Sunset Natural Products Recalls Triflex Dietary Supplement Under Consent Decree

Sunset Natural Products Inc. is recalling Triflex Dietary Supplement 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, and the recall is mandated by a consent decree requiring the destruction of all products manufactured over a three-year period, indicating significant regulatory concerns about cGMP compliance.

Plain-English summary

Sunset Natural Products Inc. is recalling Triflex Dietary Supplement (unknown container size) pursuant to a consent decree entered on September 25, 2015. 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.

The recall covers products distributed to Florida, Nevada, and the Dominican Republic. Known lot numbers include 350414, 171014, 251214, and 170115. The consent decree also requires the firm to hire a cGMP expert and receive written permission from the FDA to resume operations.

Consumers who have purchased Triflex Dietary Supplement should stop using the product and follow the instructions provided by the recalling firm or the FDA regarding disposal or return.

The recalled product

Product
Triflex Dietary Supplement (unknown container size)
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 (14)

  • 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: Lot # 350414
  • 171014
  • 251214
  • 170115

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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