Sunset Natural Products Recalls Ginko Biloba Capsules Under Consent Decree
Sunset Natural Products Inc. is recalling Ginko Biloba 150 mg capsules pursuant to a consent decree requiring the destruction of supplements distributed since April 2014.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the recall is mandated by a consent decree requiring the destruction of all products, which aligns with the 'Severe' criteria for significant regulatory action and potential non-compliance with cGMP.
Plain-English summary
Sunset Natural Products Inc. is recalling Ginko Biloba 150 mg bulk capsules. The recall is being conducted pursuant to a consent decree that prohibits the company and its owners from marketing dietary supplements until they recall and destroy the products manufactured or distributed since April 2, 2014, hire a cGMP expert, and receive written permission from the FDA to resume operations.
The recall covers 900,000 capsules distributed to Florida, Nevada, and the Dominican Republic. The consent decree was entered on September 25, 2015. Known lots include #470514, #400814, #100914, #271114, #370115, and #540614, with expiration dates ranging from August 2017 to February 2018.
Consumers who have purchased these products should stop using them and follow the instructions provided by the recalling firm or the FDA regarding the return or destruction of the product.
The recalled product
- Product
- Ginko Biloba 150 mg, bulk capsules
- Manufacturer
- Sunset Natural Products Inc.
- Category
- Food — Dietary Supplement
- Affected units
- 900,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- 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
- 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
Distribution
Part of a larger recall action
This product is one of 163 recalled by Sunset Natural Products Inc. under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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