Terminated Class II

Sundial Herbal Products

Recall F-1451-2020 · Bronx, NY

Product

"SUNDIAL Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***CERASEE***1 oz.***USES: DIABETES, HYPERTENSION, WORMS, DYSENTERY, MALARIA, BLOOD PURIFIER"; packaged in clear 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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