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Safety Report: Golden Nutrition Anti-Viral Immune Enhancement Capsules - recalled due to Unsubstantiated Health Claims on Label, Puerto Rico

4 years ago source fda.gov

Recall notice

Puerto Rico

Company name: Golden Nutrition Inc.
Brand name: Golden Nutrition Inc.
Product recalled: Anti-Viral Immune Enhancement Capsules
Reason of the recall: Unsubstantiated Health Claims on Label
FDA Recall date: June 23, 2020
Recall details: Golden Nutrition Inc. of Opa Locka, Florida is recalling four (4) Lots of Anti-Viral Immune Enhancement Capsules because the label makes unsubstantiated health claims. The recalled Anti-Viral Immune Enhancement were distributed to distributors through orders. The distribution is in Puerto Rico where consumers are able to get the product via retailers.

The product of 60 capsules comes in a green 150cc PET Bottle, with a gold cap marked with lot and expiration number on the bottom of the bottle. The Lot and expiration numbers that are being recalled are the following: Lot:1493 with Expiration: 04/2023, Lot:1499 with Expiration: 04/2023, Lot:1513 with Expiration:05/2023, and Lot:1515 with Expiration 05/2023.  

No illnesses have been reported to date in connection with this problem.

The noncompliance with FDA regulations for label claims was noted after one of our distributors brought it to our attention. The label makes unsubstantiated health claims that the product “helps fight corona virus and influenza.” Consumers that use this product instead of seeking medical treatment run the risk of serious, life threatening health consequences. The production of the product has been suspended while the company works to correct the label. Consumers who have purchased the Anti-Viral Immune Enhancement are urged to return them to the place of purchase for a full refund.

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/golden-nutrition-inc-recalls-anti-viral-immune-enhancement-because-labels-are-not-compliance

Source: FDA

#drugs #puertorico

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