Drug & medication recalls High risk

Alpha-Tek LLC recalls ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UP…

Recall date
July 16, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0001-2022
FDA classification
Class I
Brand / firm
Alpha-Tek LLC
Sold / distributed
Nationwide in the US

Why it was recalled

Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil

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

ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC 8 60003 03770 6. Also manufactured for and distributed by: Alpha Male Plus, Tucson, AZ UPC 8 60003 74518 2 (pouch), UPC 8 60003 74512 0(carton)

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