Sunset Natural Products Inc.

Recall #F-0937-2017 · Initiated 2015-10-13

Plain-language summary

by FoodRecallsDB.info

What happened

Sunset Natural Products Inc. is recalling Prostax Forte capsules because the company violated FDA regulations for how dietary supplements must be made and quality-tested. The FDA has ordered the company to stop selling supplements and remove these products from the market.

Who is at risk

Anyone who purchased Prostax Forte capsules, particularly in Florida, Nevada, or the Dominican Republic, should be aware of this recall.

What to do

If you have Prostax Forte capsules, stop using them and contact the manufacturer or your retailer for instructions on returning or discarding the product. You can also visit the FDA website for more information about this recall.

Product

Prostax Forte, (50,000 capsule bulk)

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

100,000 capsules

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 lots and expiration dates: Lot # 300614 Exp. Date 06/17, Lot # 480614 Exp. Date 10/17

Voluntary / mandated

FDA Mandated

Initial notification

Letter

Terminated

2017-04-10