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Class II

Sunset Natural Products Inc.

Recall #F-0617-2016 · Initiated 2015-10-05

Product
Hepasil, sold in bulk of 500,000 capsules.
Reason for recall
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.
Quantity affected
500,000 capsules
Distribution
FL and NV
Lot / code info
Lot # 080315 Exp. Date 03/18
Voluntary / mandated
FDA Mandated
Initial notification
Other
Terminated
2017-04-10

Recalling firm

Sunset Natural Products Inc.
7345 SW 45th St
Miami, FL 33155-4509
United States

Recall classification

Remote probability of serious adverse health consequences, or temporary reversible consequences.

Other recalls from Sunset Natural Products Inc.

Colon Therapy, bulk capsules
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Oyster Dietary Supplement (unknown container size)
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Liver Energy, 100 capsules per bottle
Class II2015-10-13