The Recall Desk
SevereFDA (Food)·F-0960-2017·Announced 2017-01-04

Sunset Natural Products Recalls Prostaliv Dietary Supplement Under Consent Decree

Sunset Natural Products Inc. is recalling Prostaliv dietary supplements pursuant to a consent decree requiring the destruction of products 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, and the recall is mandated by a consent decree requiring the destruction of all products, which aligns with the 'Severe' criteria for significant regulatory action and potential non-compliance with cGMPs.

Plain-English summary

Sunset Natural Products Inc. is recalling Prostaliv, 60 capsules per bottle, pursuant to a consent decree with the U.S. Food and Drug Administration. The recall involves 20,499 bottles (1,500,000 capsules) distributed to Florida, Nevada, and the Dominican Republic. The consent decree prohibits the company and its owners from marketing dietary supplements until they recall and destroy all products manufactured or distributed since April 2, 2014, hire a cGMP expert, and receive written permission from the FDA to resume operations.

The recall is mandated by the decree entered on September 25, 2015, which requires the firm to 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. Known lots include #390514, #350614, #630614, #640614, #670614, #421014, and #431014, with expiration dates ranging from June 2017 to December 2017.

Consumers who have purchased Prostaliv from Sunset Natural Products Inc. should stop using the product and follow the instructions provided by the recalling firm or the FDA for disposal or return, as required by the consent decree.

The recalled product

Product
Prostaliv, 60 capsules per bottle
Manufacturer
Sunset Natural Products Inc.
Category
Food — Dietary Supplement
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 (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 # 390514 Exp. Date 06/17
  • Lot # 350614 Exp. Date 06/17
  • Lot # 630614 Exp. Date 06/17
  • Lot # 640614 Exp. Date 06/17
  • Lot # 670614 Exp. Date 08/17
  • Lot # 421014 Exp. Date 11/17
  • Lot # 431014 Exp. Date 12/17

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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