Class IITerminated in FDA datasetRecall initiated Oct 13, 2015

Ginko Biloba 150 mg, 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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ProductGinko Biloba 150 mg, 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 # 470514 Exp. Date 06/17, Lot # 400814 Exp. Date 09/17, Lot # 100914 Exp. Date 09/17, Lot # 271114 Exp. Date 12/17, Lot # 370115 Exp. Date 02/18, Lot # 540614 Exp. Date 08/18

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Full FDA record and distribution details

Original product description

Ginko Biloba 150 mg, bulk capsules

Extracted codes and context

TypeCode / valueContext
lot100914ration dates: Lot # 470514 Exp. Date 06/17, Lot # 400814 Exp. Date 09/17, Lot # 100914 Exp. Date 09/17, Lot # 271114 Exp. Date 12/17, Lot # 370115 Exp. Date 02/18, Lot # 540614 Exp. Date 08/18
lot271114. Date 06/17, Lot # 400814 Exp. Date 09/17, Lot # 100914 Exp. Date 09/17, Lot # 271114 Exp. Date 12/17, Lot # 370115 Exp. Date 02/18, Lot # 540614 Exp. Date 08/18
lot370115. Date 09/17, Lot # 100914 Exp. Date 09/17, Lot # 271114 Exp. Date 12/17, Lot # 370115 Exp. Date 02/18, Lot # 540614 Exp. Date 08/18
lot400814, 2015. Known lots and expiration dates: Lot # 470514 Exp. Date 06/17, Lot # 400814 Exp. Date 09/17, Lot # 100914 Exp. Date 09/17, Lot # 271114 Exp. Date 12/17, Lot # 370115 Exp. Date 02/18, Lot # 540614
lot470514ee was entered on September 25, 2015. Known lots and expiration dates: Lot # 470514 Exp. Date 06/17, Lot # 400814 Exp. Date 09/17, Lot # 100914 Exp. Date 09/17, Lot # 271114 Exp. Date 12/17, Lot # 370115
lot540614. Date 09/17, Lot # 271114 Exp. Date 12/17, Lot # 370115 Exp. Date 02/18, Lot # 540614 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-0982-2017
Event ID
74054
FDA status
Terminated
Initiated
Oct 13, 2015
Reported
Jan 4, 2017
Classified
Dec 28, 2016
Terminated
Apr 10, 2017
Quantity
900,000 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-0982-2017

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

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