The Recall Desk
SevereFDA (Food)·F-0985-2017·Announced 2017-01-04

Sunset Natural Products Recalls Garcro Bulk Capsules Under Consent Decree

Sunset Natural Products Inc. is recalling Garcro 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 recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the mandatory destruction of all products manufactured over a three-year period under a consent decree.

Plain-English summary

Sunset Natural Products Inc. is recalling Garcro, bulk capsules, pursuant to a consent decree entered on September 25, 2015. The decree prohibits the company and its owners from marketing dietary supplements until they recall and destroy all dietary supplements manufactured, prepared, processed, packed, labeled, held, and/or distributed between April 2, 2014, and the date of the decree's entry. The recall covers 1,530,000 capsules.

The recall is being conducted under FDA supervision in accordance with the procedures provided in the consent decree. The company is also required to 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.

Known lots and expiration dates include Lot # 020614 (Exp. 08/17), Lot # 450714 (Exp. 08/17), Lot # 410814 (Exp. 09/17), Lot # 420814 (Exp. 08/17), and Lot # 510914 (Exp. 10/17). Consumers should stop using the product and follow instructions provided by the recalling firm or FDA.

The recalled product

Product
Garcro, bulk capsules
Manufacturer
Sunset Natural Products Inc.
Category
Food — Dietary Supplement
Hazard
Affected units
1,530,000

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 # 020614 Exp. Date 08/17
  • Lot # 450714 Exp. Date 08/17
  • Lot # 410814 Exp. Date 09/17
  • Lot # 420814 Exp. Date 08/17
  • Lot # 510914 Exp. Date 10/17

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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