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Recall Observatory FDA recall evidence

Food product

Artrosamin, 250,000 capsules per bulk order

F-0933-2017

October 13, 2015

Class II

Product summary

Firm
Sunset Natural Products Inc.
Event
Event 74054
Status
Terminated
Classification
Class II
Quantity
3,000,000 capsules
Official record key
food-enforcement:F-0933-2017

Official wording

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.

Code information: 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,

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.