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Recall Observatory FDA recall evidence

Food product

Vital Cure, 30 capsules per bottle

F-0964-2017

October 13, 2015

Class II

Product summary

Firm
Sunset Natural Products Inc.
Event
Event 74054
Status
Terminated
Classification
Class II
Quantity
189,533 Bottles, (6,136,000 capsules)
Official record key
food-enforcement:F-0964-2017

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 # 660614, 560714 Exp. Date 07/17, Lot # 090814 Exp. Date 09/17, Lot # 280914 Exp. Date 09/17, Lot # 290914 Exp. Date 10/17, Lot # 261014 Exp. Date 11/17, Lot # 211114 Exp. Date 12/17, Lot # 011214 Exp. Date 12/17, Lot # 280115 Exp. Date 01/18, Lot # 230215 Exp. Date 03/18, Lot # 090315 Exp. Date 03/18, Lot # 520315 Exp. Date 03/18, Lot # 060515 Exp. Date 05/18, Lot # 310515 Exp. Date 06/18, Lot # 380515 Exp. Date 06/18, Lot # 120615 Exp. Date 07/18, Lot # 440615 Exp. Date 06/18, Lot # 090715 Exp. Date 07/18, Lot # 210715 Exp. Date 07/18, Lot # 220715 Exp. Date 08/18, Lot # 230715 Exp. Date 08/18, Lot # 210815 Exp. Date 08/18, Lot # 140415 Exp. Date 04/18

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.