Tiger-X recalled over undeclared sildenafil

Recall date

May 12, 2016

Source

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

Official notice title

SOS Telecom Inc. recalls Tiger-X, 1200 mg, 1 capsule per pack , 24 single packs per box

Recall number

D-0101-2017

FDA classification

Class I

Brand / firm

SOS Telecom Inc.

Sold / distributed

NY

Why it was recalled

Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements

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

Tiger-X, 1200 mg, 1 capsule per pack , 24 single packs per box