The Recall Desk
SevereFDA (Food)·F-0978-2017·Announced 2017-01-04

Sunset Natural Products Recalls Colon Therapy Capsules Under Consent Decree

Sunset Natural Products Inc. is recalling Colon Therapy 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, and the recall is mandated by a consent decree requiring the destruction of all products manufactured since 2014, which aligns with the 'Severe' criteria for significant regulatory intervention and potential risk.

Plain-English summary

Sunset Natural Products Inc. is recalling 19,455,300 units of Colon Therapy, bulk capsules. The recall is being conducted pursuant to a consent decree that prohibits the company and its owners from marketing dietary supplements until they recall and destroy the products manufactured or distributed since April 2, 2014, hire a cGMP expert, and receive written permission from the FDA to resume operations.

The affected products were distributed to Florida, Nevada, and the Dominican Republic. The consent decree was entered on September 25, 2015. The source text lists specific lot numbers and expiration dates for the recalled items.

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 supplements.

The recalled product

Product
Colon Therapy, bulk capsules
Manufacturer
Sunset Natural Products Inc.
Category
Food — Dietary Supplement
Hazard
Affected units
19,455,300

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 (20)

  • 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 # 020514 Exp. Date 05/17
  • Lot # 030514 Exp. Date 05/17
  • Lot # 040514 Exp. Date 05/17
  • Lot # 140514 Exp. Date 06/17
  • Lot # 150514 Exp. Date 06/17
  • Lot # 440514 Exp. Date 05/17
  • Lot # 500514 Exp. Date 05/17
  • Lot # 510514 Exp. Date 05/17
  • Lot # 520514 Exp. Date 05/17
  • Lot # 530514 Exp. Date 05/17

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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