Class IITerminated in FDA datasetRecall initiated Oct 13, 2015

Zinc Gluconate, bulk capsules

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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ProductZinc Gluconate, bulk capsules

FDA 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 # 130414 Exp. Date 04/17, Lot # 261214 Exp. Date 12/17, Lot # 040815 Exp. Date 08/18

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Full FDA record and distribution details

Original product description

Zinc Gluconate, bulk capsules

Extracted codes and context

TypeCode / valueContext
lot040815ation dates: Lot # 130414 Exp. Date 04/17, Lot # 261214 Exp. Date 12/17, Lot # 040815 Exp. Date 08/18
lot130414ee was entered on September 25, 2015. Known lots and expiration dates: Lot # 130414 Exp. Date 04/17, Lot # 261214 Exp. Date 12/17, Lot # 040815 Exp. Date 08/18
lot261214, 2015. Known lots and expiration dates: Lot # 130414 Exp. Date 04/17, Lot # 261214 Exp. Date 12/17, Lot # 040815 Exp. Date 08/18

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

Recall details

Recall number
F-0969-2017
Event ID
74054
FDA status
Terminated
Initiated
Oct 13, 2015
Reported
Jan 4, 2017
Classified
Dec 28, 2016
Terminated
Apr 10, 2017
Quantity
1,540,000 capsules
Location
Miami, FL, United States
Initiation type
FDA Mandated
Notification
Letter

Where it was distributed

Products distributed to Florida, Nevada and the Dominican Republic

FDA source record · F-0969-2017

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

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