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Recall Observatory FDA recall evidence

Food product

Collagen & VIT C, 60 capsules per bottle

F-0929-2017

October 13, 2015

Class II

Product summary

Firm
Sunset Natural Products Inc.
Event
Event 74054
Status
Terminated
Classification
Class II
Quantity
23,100 Bottles (1,364,000 capsules)
Official record key
food-enforcement:F-0929-2017

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 # 160415 Exp. Date 04/18, Lot # 270415 Exp. Date 04/18, Lot # 280415 Exp. Date 06/18, Lot # 290415 Exp. Date 05/18, Lot # 550615 Exp. Date 06/18, Lot # 560615 Exp. Date 07/18, Lot # 530814 Exp. Date 09/17, Lot # 120115 Exp. Date 01/17, Lot # 360515 Exp. Date 06/18

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.