The Recall Desk
SevereFDA (Food)·F-1000-2017·Announced 2017-01-04

Sunset Natural Products Recalls Pritos Bulk Capsules Under Consent Decree

Sunset Natural Products Inc. is recalling Pritos bulk capsules pursuant to a consent decree requiring the destruction of supplements 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 under the rubric, particularly given the context of a consent decree requiring the destruction of all products manufactured over a three-year period.

Plain-English summary

Sunset Natural Products Inc. is recalling Pritos, bulk capsules, 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 supplements manufactured or distributed since April 2, 2014, hire a cGMP expert, and receive written permission from the FDA to resume operations.

The recall covers 660,000 capsules distributed to Florida, Nevada, and the Dominican Republic. Known lots include Lot # 020415 with an expiration date of 05/18 and Lot # 080515 with an expiration date of 06/18. The agency classification for this recall is Class II.

Consumers who have purchased these products should stop using them and follow the instructions provided by the recalling firm or the FDA regarding the destruction of the product.

The recalled product

Product
Pritos, bulk capsules
Manufacturer
Sunset Natural Products Inc.
Category
Food — Dietary Supplements
Hazard
Affected units
660,000

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 # 020415 Exp. Date 05/18
  • Lot # 080515 Exp. Date 06/18

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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