Sunset Natural Products Inc.

Recall #F-0982-2017 · Initiated 2015-10-13

Plain-language summary

by FoodRecallsDB.info

What happened

Sunset Natural Products Inc. has been ordered to recall Ginkgo Biloba 150 mg capsules due to violations of manufacturing safety standards. The company is prohibited from selling dietary supplements until it meets specific FDA requirements and receives permission to resume operations.

Who is at risk

Anyone who purchased Ginkgo Biloba 150 mg capsules from this company in Florida, Nevada, or the Dominican Republic should be aware of this recall.

What to do

Check if you have this product at home by looking at the bottle label for the manufacturer name 'Sunset Natural Products Inc.' If you have it, stop using it and contact the company or your retailer for information about returns or refunds.

Product

Ginko Biloba 150 mg, bulk 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 manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.

Quantity affected

900,000 capsules

Distribution

Products distributed to Florida, Nevada and the Dominican Republic

Lot / code info

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

Voluntary / mandated

FDA Mandated

Initial notification

Letter

Terminated

2017-04-10