Drug & medication recalls High risk

TORNADO Male Enhancement Herbal Dietary Supplement Capsules recalled over undeclared tadalafil

Recall date
April 18, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Organic Herbal Supply recalls TORNADO Male Enhancement Herbal Dietary Supplement Capsules, Over 4000 mg value, supplied in 2, 4 and 10 count packages…
Recall number
D-0966-2017
FDA classification
Class I
Brand / firm
Organic Herbal Supply
Sold / distributed
Nationwide via internet

Why it was recalled

Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin

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

TORNADO Male Enhancement Herbal Dietary Supplement Capsules, Over 4000 mg value, supplied in 2, 4 and 10 count packages, Made in USA Distributed by American Health Supplements, Chicago, Illinois --- UPC Code 680474228959

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