The Recall Desk
SevereFDA (Food)·F-0966-2017·Announced 2017-01-04

Sunset Natural Products Recalls Pinateina Dietary Supplement Under Consent Decree

Sunset Natural Products Inc. is recalling Pinateina 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 prohibiting future marketing until corrective actions are taken, which aligns with the 'Severe' criteria for significant regulatory intervention.

Plain-English summary

Sunset Natural Products Inc. is recalling Pinateina dietary supplements. The recall is being conducted pursuant to a consent decree that prohibits the company and its owners from marketing dietary supplements until specific conditions are met. The decree 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 the decree was entered on September 25, 2015.

The recall covers 500 bottles of Pinateina. The products were distributed to Florida, Nevada, and the Dominican Republic. Known lot information includes Lot # 550315 with an expiration date of 04/18.

Consumers who possess the recalled product should stop using it and follow the instructions provided by the recalling firm or the FDA regarding the destruction of the supplements.

The recalled product

Product
Pinateina
Affected units
500

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 # 550315 Exp. Date 04/18

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 →