Home / Sunset Natural Products Inc. / F-0960-2017
Class II
Sunset Natural Products Inc.
Recall #F-0960-2017 · Initiated 2015-10-13
Plain-language summary
by FoodRecallsDB.infoWhat happened
The FDA has ordered Sunset Natural Products Inc. to recall all bottles of Prostaliv dietary supplements made since April 2014 because the company violated manufacturing and safety standards. The company is prohibited from selling dietary supplements until it meets FDA requirements and receives permission to resume operations.
Who is at risk
Anyone who purchased Prostaliv capsules distributed in Florida, Nevada, or the Dominican Republic should be aware of this recall.
What to do
Stop using Prostaliv if you have a bottle and contact Sunset Natural Products Inc. or your retailer for a refund. Do not use the product, as it was manufactured without proper FDA oversight and quality controls.
Product
Prostaliv, 60 capsules per bottle
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
20,499 Bottles, (1,500,000 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 # 390514 Exp. Date 06/17, Lot # 350614 Exp. Date 06/17, Lot # 630614 Exp. Date 06/17, Lot # 640614 Exp. Date 06/17, Lot # 670614 Exp. Date 08/17, Lot # 421014 Exp. Date 11/17, Lot # 431014 Exp. Date 12/17
Voluntary / mandated
FDA Mandated
Initial notification
Letter
Terminated
2017-04-10
Recalling firm
Sunset Natural Products Inc.
7345 SW 45th St
Miami, FL 33155-4509
United States
Recall classification
Remote probability of serious adverse health consequences, or temporary reversible consequences.