Sunset Natural Products Inc.

Recall #F-1014-2017 · Initiated 2015-10-13

Plain-language summary

by FoodRecallsDB.info

What happened

Sunset Natural Products Inc. has been ordered by the FDA to recall all Nutriplex Dietary Supplement products distributed since April 2, 2014, because the company failed to follow proper manufacturing practices and safety requirements. The company cannot sell dietary supplements until it meets FDA standards and receives permission to resume operations.

Who is at risk

Anyone who purchased Nutriplex Dietary Supplement products, particularly those in Florida, Nevada, or the Dominican Republic.

What to do

Stop using any Nutriplex Dietary Supplement products you own. Contact the place where you purchased it for a refund, or dispose of the product safely. If you have questions, contact your healthcare provider or the FDA.

Product

Nutriplex Dietary Supplement (unknown container size)

Reason for recall

Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.

Quantity affected

Unknown

Distribution

Products distributed to Florida, Nevada and the Dominican Republic

Lot / code info

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, 2014 and the date of entry of this Decree." The Decree was entered on September 25, 2015. Known lot: Lot # 071014

Voluntary / mandated

FDA Mandated

Initial notification

Letter

Terminated

2017-04-10