The Recall Desk
ModerateFDA (Food)·F-0958-2017·Announced 2017-01-04

Sunset Natural Products Recalls Chardon De Marie Dietary Supplement

Sunset Natural Products Inc. is recalling Chardon De Marie capsules pursuant to a consent decree requiring the destruction of supplements manufactured since April 2014.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is a voluntary precautionary action mandated by a consent decree to ensure compliance with cGMP regulations, with no specific health hazard or reported illnesses cited in the source text.

Plain-English summary

Sunset Natural Products Inc. is recalling Chardon De Marie, 60 capsules per bottle, pursuant to a consent decree with the U.S. Food and Drug Administration. The recall covers 23,665 bottles, containing a total of 1,420,000 capsules. The affected products were distributed to Florida, Nevada, and the Dominican Republic.

The recall is mandated by a consent decree that prohibits the company and its owners from marketing dietary supplements until specific conditions are met. These conditions include the recall and destruction of all dietary supplements 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 company is also required to hire a cGMP expert and receive written permission from the FDA to resume operations.

Consumers who have purchased Chardon De Marie capsules should check their lot numbers and expiration dates against the following list: Lot # 290414 (Exp. 04/17), Lot # 280414 (Exp. 05/17), Lot # 660514 (Exp. 06/17), Lot # 030714 (Exp. 07/17), Lot # 670514 (Exp. 07/17), Lot # 680514 (Exp. 10/17), Lot # 131214 (Exp. 12/17), and Lot # 151214 (Exp. 02/18). The source text does not specify a particular health hazard or reported illnesses associated with this recall.

The recalled product

Product
Chardon De Marie, 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 (18)

  • 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 # 290414 Exp. Date 04/17
  • Lot # 280414 Exp. Date 05/17
  • Lot # 660514 Exp. Date 06/17
  • Lot # 030714 Exp. Date 07/17
  • Lot # 670514 Exp. Date 07/17
  • Lot # 680514 Exp. Date 10/17
  • Lot # 131214 Exp. Date 12/17
  • Lot # 151214 Exp. Date 02/18

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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