Sunset Natural Products Inc.

Recall #F-1011-2017 · 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 Prostate Plus Dietary Supplement products distributed since April 2, 2014, due to the company's failure to follow proper manufacturing and safety standards. The company is prohibited from selling dietary supplements until it meets specific FDA requirements.

Who is at risk

Anyone who purchased Prostate Plus Dietary Supplement from this company in Florida, Nevada, or the Dominican Republic should be aware of this recall.

What to do

Check if you have this product at home and stop using it immediately. Contact the retailer or Sunset Natural Products Inc. for information on how to return or dispose of the product safely. If you have any health concerns after using this supplement, contact your doctor or poison control.

Product

Prostate Plus 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 # 140715

Voluntary / mandated

FDA Mandated

Initial notification

Letter

Terminated

2017-04-10