Class IITerminated in FDA datasetRecall initiated Oct 5, 2015

Prostamax DUO, 60 capsules per bottle.

Recalling firm: Sunset Natural Products Inc.

Why it was recalled

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…

Historical recall record. This is not a new recall announcement. “Terminated” describes the FDA recall process; it does not certify that an individual package is safe. FDA termination date: Apr 10, 2017.

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ProductProstamax DUO, 60 capsules per bottle. Manufactured by Sunset Natural Products
UPC850993004055

FDA code information

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

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Full FDA record and distribution details

Original product description

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

Extracted codes and context

TypeCode / valueContext
UPC850993004055Lot # 140515 Exp. Date 05/18 UPC 850993004055,
lot140515Lot # 140515 Exp. Date 05/18 UPC 850993004055,

Original FDA recall 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.

Recall details

Recall number
F-0542-2016
Event ID
72877
FDA status
Terminated
Initiated
Oct 5, 2015
Reported
Feb 24, 2016
Classified
Feb 17, 2016
Terminated
Apr 10, 2017
Quantity
4,000 bottles (240,000 capsules)
Location
Miami, FL, United States
Initiation type
FDA Mandated
Notification
Other

Where it was distributed

FL and NV

FDA source record · F-0542-2016

Data updated September 16, 2026. View official FDA data ↗

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