The Recall Desk
SevereFDA (Food)·F-0962-2017·Announced 2017-01-04

Sunset Natural Products Recalls Moinsage Dietary Supplement Under Consent Decree

Sunset Natural Products Inc. is recalling Moinsage 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, and the recall is mandated by a consent decree requiring the destruction of all products, which aligns with the 'Severe' criteria for significant regulatory enforcement actions.

Plain-English summary

Sunset Natural Products Inc. is recalling Moinsage, 60 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 the decree was entered on September 25, 2015. The company must also hire a cGMP expert and receive written permission from the FDA to resume operations.

The recall involves 28,666 bottles, containing a total of 1,720,000 capsules. The products were distributed to Florida, Nevada, and the Dominican Republic. Specific lot numbers and expiration dates associated with the recall include Lot # 420514 (Exp. 07/17), Lot # 090614 (Exp. 07/17), Lot # 140814 (Exp. 09/17), Lot # 150814 (Exp. 10/17), Lot # 401014 (Exp. 11/17), Lot # 340614 (Exp. 06/17), and Lot # 411014 (Exp. 11/17).

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
Moinsage, 60 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 (17)

  • 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 # 420514 Exp. Date 07/17
  • Lot # 090614 Exp. Date 07/17
  • Lot # 140814 Exp. Date 09/17
  • Lot # 150814 Exp. Date 10/17
  • Lot # 401014 Exp. Date 11/17
  • Lot # 340614 Exp. Date 06/17
  • Lot # 411014 Exp. Date 11/17

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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