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Recall Observatory FDA recall evidence

Food product

Prostamax DUO, 60 capsules per bottle. Manufactured by Sunset Natural Products

F-0542-2016

October 05, 2015

Class II

Product summary

Firm
Sunset Natural Products Inc.
Event
Event 72877
Status
Terminated
Classification
Class II
Quantity
4,000 bottles (240,000 capsules)
Official record key
food-enforcement:F-0542-2016

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 manufatured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.

Code information: Lot # 140515 Exp. Date 05/18 UPC 850993004055,

Distribution pattern: FL and NV

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 manufatured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.