The Recall Desk
SevereFDA (Food)·F-0976-2017·Announced 2017-01-04

Sunset Natural Products Recalls Arganine & Pine Bark Capsules Under Consent Decree

Sunset Natural Products Inc. is recalling 1,335,000 capsules of Arganine & Pine Bark 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 over a three-year period, indicating significant regulatory concerns regarding the firm's compliance with cGMPs.

Plain-English summary

Sunset Natural Products Inc. is recalling 1,335,000 capsules of Arganine & Pine Bark. The recall is being conducted pursuant to a consent decree entered on September 25, 2015, which 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.

The affected products were distributed to Florida, Nevada, and the Dominican Republic. Specific lots involved include Lot # 470414 (Exp. 06/17), Lot # 420714 (Exp. 08/17), Lot # 020914 (Exp. 10/17), Lot # 231214 (Exp. 01/18), and Lot # 220615 (Exp. 07/18). The consent decree also requires the firm to hire a cGMP expert and receive written permission from the FDA to resume operations.

Consumers who have purchased these products should stop using them and follow the instructions provided by the recalling firm or the FDA for disposal or return, as the products are subject to destruction under FDA supervision.

The recalled product

Product
Arganine & Pine Bark, bulk capsules
Manufacturer
Sunset Natural Products Inc.
Category
Food — Dietary Supplements
Hazard
Affected units
1,335,000

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 (15)

  • 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 # 470414 Exp. Date 06/17
  • Lot # 420714 Exp. Date 08/17
  • Lot # 020914 Exp. Date 10/17
  • Lot # 231214 Exp. Date 01/18
  • Lot # 220615 Exp. Date 07/18

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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