Sunset Natural Products Inc.

Recall #F-1018-2017 · 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 Power Max Dietary Supplement products distributed since April 2014 due to the company violating manufacturing safety rules. The company is prohibited from selling dietary supplements until it meets specific safety requirements and gets FDA approval to restart.

Who is at risk

Anyone who purchased Power Max Dietary Supplement from this company, particularly those in Florida, Nevada, or the Dominican Republic.

What to do

Check if you have this product at home and stop using it. Contact the manufacturer or retailer where you purchased it for instructions on returning the product, or dispose of it safely. If you have any health concerns after using this product, consult your healthcare provider.

Product

Power Max 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 # 540814, 100815

Voluntary / mandated

FDA Mandated

Initial notification

Letter

Terminated

2017-04-10