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Recall Observatory FDA recall evidence

Food product

Moinsage, 60 capsules per bottle

F-0962-2017

October 13, 2015

Class II

Product summary

Firm
Sunset Natural Products Inc.
Event
Event 74054
Status
Terminated
Classification
Class II
Quantity
28,666 Bottles, (1,720,000 capsules)
Official record key
food-enforcement:F-0962-2017

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 # 420514 Exp. Date 07/17, Lot # 090614 Exp. Date 07/17, Lot # 140814 Exp. Date 09/17, Lot # 150814 Exp. Date 10/17, Lot # 401014 Exp. Date 11/17, Lot # 340614 Exp. Date 06/17, Lot # 411014 Exp. Date 11/17

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.