The Recall Desk
SevereFDA (Food)·F-0968-2017·Announced 2017-01-04

Sunset Natural Products Recalls Coclss Bulk Capsules Under Consent Decree

Sunset Natural Products Inc. is recalling Coclss bulk capsules pursuant to a consent decree requiring the destruction of dietary 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, which corresponds to a score of 4 (Severe) per the rubric, as it involves a significant health risk or temporary adverse health consequences.

Plain-English summary

Sunset Natural Products Inc. is recalling Coclss bulk capsules. This action is taken pursuant to a consent decree that prohibits the company and its owners from marketing dietary supplements until they recall and destroy the products, hire a cGMP expert, and receive written permission from the FDA to resume operations.

The recall covers dietary supplements 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 specific product involved is Coclss, bulk capsules, with a total quantity of 2,400,000 capsules. Known lots include #090414, #100414, #110414, #040115, #160315, #190615, and #200615, with expiration dates ranging from 05/17 to 07/18.

The products were distributed to Florida, Nevada, and the Dominican Republic. Consumers should stop using the recalled products and follow the instructions provided by the recalling firm or the FDA regarding the destruction of these items.

The recalled product

Product
Coclss, bulk capsules
Manufacturer
Sunset Natural Products Inc.
Category
Food — Dietary Supplements
Hazard
Affected units
2,400,000

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 (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 # 090414 Exp. Date 05/17
  • Lot # 100414 Exp. Date 05/17
  • Lot # 110414 Exp. Date 05/17
  • Lot # 040115 Exp. Date 01/18
  • Lot # 160315 Exp. Date 04/18
  • Lot # 190615 Exp. Date 07/18
  • Lot # 200615 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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