Recall Number: F-0933-2017

City: Miami

State: Florida

Country: United States

Classification: Class II

Classification Date: 2016-12-28

Reason: 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.

Product Description: Artrosamin, 250,000 capsules per bulk order

Report Date: 2017-01-04

Product Type: Food

Company: Sunset Natural Products Inc.

Status: Terminated

Recall Number: F-0933-2017

Postal Code: 33155-4509

Recall Initiation Date: 2015-10-13

Recall End Date: 2017-04-10

Event ID: 74054

Distribution Pattern: Products distributed to Florida, Nevada and the Dominican Republic

Voluntary Or Mandated: FDA Mandated

Initial Firm Notification: Letter

Extra 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 # 030414 Exp. Date 04/17, Lot # 040414 Exp. Date 04/17, Lot # 050414 Exp. Date 04/17, Lot # 060414 Exp. Date 04/17, Lot # 070414 Exp. Date 04/17, Lot # 080414 Exp. Date 04/17, Lot # 010514 Exp. Date 04/17, Lot # 080514 Exp. Date 04/17, Lot # 090514 Exp. Date 04/17, Lot # 100514 Exp. Date 05/17, Lot # 110514 Exp. Date 05/17, Lot # 120514 Exp. Date 05/17,

Product Quantity: 3,000,000 capsules

Address: 7345 SW 45th St