Agency classClass IIOur severity:Severe FDA (Food)·F-0914-2017·Announced 2017-01-04

Sunset Natural Products Recalls Nutra Pro Dietary Supplements

Sunset Natural Products Inc. is recalling Nutra Pro 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 context of a consent decree requiring destruction of products due to cGMP violations.

Plain-English summary

Sunset Natural Products Inc. is recalling Nutra Pro, 60 ct. 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 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 involves 2,160 bottles (198,000 capsules) of Nutra Pro. The products were distributed to Florida, Nevada, and the Dominican Republic. The known lot number is 031014 with an expiration date of 10/17.

Consumers should stop using the recalled products and follow the procedures provided in the consent decree, which requires the firm to recall and destroy the supplements under FDA supervision. The company must also hire a cGMP expert and receive written permission from the FDA to resume operations.

The recalled product

Product: Nutra Pro, 60 ct. per bottle
Manufacturer: Sunset Natural Products Inc.
Category: Food — Dietary Supplements
Hazard: cGMP-violation
contamination

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 # 031014 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 →

Same manufacturer · Sunset Natural Products Inc.

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