The Recall Desk
Agency classClass IIOur severity:SevereFDA (Food)·F-0938-2017·Announced 2017-01-04

Sunset Natural Products Recalls Magnumn Dietary Supplements Under Consent Decree

Sunset Natural Products Inc. is recalling Magnumn dietary supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

The agency’s classification

FDA (Food): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 Magnumn dietary supplements (30 per bottle) 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 products manufactured, prepared, processed, packed, labeled, held, and/or distributed between April 2, 2014, and the date of the decree's entry.

The recall covers 400 bottles of Magnumn, distributed to Florida, Nevada, and the Dominican Republic. Known lot information includes Lot # 040315 with an expiration date of 03/18. 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
Magnumn, (30 per bottle)
Manufacturer
Sunset Natural Products Inc.
Category
Food — Dietary Supplements
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 (11)

  • 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 lot and expiration date: Lot # 040315 Exp. Date 03/18

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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