The Recall Desk
SevereFDA (Food)·F-0912-2017·Announced 2017-01-04

Sunset Natural Products Recalls Project #2 Dietary Supplement Capsules

Sunset Natural Products Inc. is recalling Project #2 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 severity score of 4 (Severe) per the rubric, as it involves a significant risk of temporary or medically reversible adverse health consequences.

Plain-English summary

Sunset Natural Products Inc. is recalling Project #2, 90 capsules per bottle, pursuant to a consent decree with the U.S. Food and Drug Administration. The recall involves 1,000 bottles (90,000 capsules) of the dietary supplement. The known lot number is 011014 with an expiration date of 10/17.

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 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 decree also requires the firm to hire a cGMP expert and receive written permission from the FDA to resume operations.

The products were distributed to Florida, Nevada, and the Dominican Republic. Consumers should stop using the recalled product and follow the instructions provided by the recalling firm or the FDA for disposal or return.

The recalled product

Product
Project #2, 90 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 (11)

  • 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 # 011014 Exp. Date 10/17

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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