SUPER HERBS 350 mg recalled over undeclared sibutramine

Recall date

November 23, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Super Herbs recalls SUPER HERBS 350 mg, 30 capsules per bottle.

Recall number

D-0909-2016

FDA classification

Class I

Brand / firm

Super Herbs

Sold / distributed

9 consignees - only 9 bottles distributed

Why it was recalled

Marketed without an approved NDA/ANDA - presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and/or phenolphthalein.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

SUPER HERBS 350 mg, 30 capsules per bottle.