Sunset Natural Products Inc.

Recall #F-1032-2017 · 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 Proga Dietary Supplements distributed since April 2, 2014, due to the company's failure to follow proper manufacturing and quality control procedures. The company cannot sell dietary supplements again until it meets specific FDA requirements.

Who is at risk

Anyone who purchased Proga Dietary Supplement from this company should be concerned, as the safety and quality of the product cannot be verified.

What to do

If you have a Proga Dietary Supplement made by Sunset Natural Products Inc., stop using it and dispose of it safely. Contact the company or your retailer if you have questions about whether your product is affected by this recall.

Product

Proga 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 # 010914

Voluntary / mandated

FDA Mandated

Initial notification

Letter

Terminated

2017-04-10