Terminated Class II

Sundial Herbal Products

Recall F-1462-2020 · Bronx, NY

Product

"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BLACK SAGE***1 oz.***USES: ALZHEIMER'S DISEASE, GINGIVITIS, MENOPAUSE, APPLY DIRECTLY TO SKIN FOR COLD SORES, ASTHMA***"; packaged in clear plastic zip-top bags

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

Distribution

NY

Quantity affected

Unknown

Recall type

FDA Mandated

Lot / code info

Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.

Timeline

30 Jun 2020 initiated 15 Sep 2020 classified 9 Sep 2020 reported 26 Oct 2022 terminated

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