The Recall Desk
SevereFDA (Food)·F-0998-2017·Announced 2017-01-04

Sunset Natural Murine Bulk Capsules Recalled Under Consent Decree

Sunset Natural Products Inc. is recalling Murine 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 agency classification is FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the mandatory destruction of products under a consent decree.

Plain-English summary

Sunset Natural Products Inc. is recalling Murine, 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 supplements manufactured, prepared, processed, packed, labeled, held, and/or distributed between April 2, 2014, and the date of the decree's entry.

The recall involves 1,710,000 capsules. The products were distributed to Florida, Nevada, and the Dominican Republic. Known lots include #120814 (Exp. 08/17), #130914 (Exp. 09/17), #101014 (Exp. 11/17), #330215 (Exp. 03/18), and #210515 (Exp. 06/18). The firm agreed to recall and destroy these products under FDA's supervision and to hire a cGMP expert before receiving written permission to resume operations.

Consumers who have purchased these products should stop using them and follow the instructions provided by the recalling firm or FDA regarding disposal or return.

The recalled product

Product
Murine, bulk capsules
Manufacturer
Sunset Natural Products Inc.
Category
Food — Dietary Supplement
Hazard
Affected units
1,710,000

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 # 120814 Exp. Date 08/17
  • Lot # 130914 Exp. Date 09/17
  • Lot # 101014 Exp. Date 11/17
  • Lot # 330215 Exp. Date 03/18
  • Lot # 210515 Exp. Date 06/18

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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