MIRACLE ROCK 48 capsules recalled over undeclared thiosildenafil

Recall date

August 27, 2015

Source

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

Official notice title

The One Minute Miracle Inc recalls MIRACLE ROCK 48 capsules, packaged in 2 x 2-count blisters, 4-count capsules per carton, Manufactured Exclusively For:…

Recall number

D-0229-2016

FDA classification

Class I

Brand / firm

The One Minute Miracle Inc

Sold / distributed

Nationwide

Why it was recalled

Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain undeclared thiosildenafil, an analogue of an FDA approved drug for male erectile dysfunchtion making this product an unapproved drug.

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

MIRACLE ROCK 48 capsules, packaged in 2 x 2-count blisters, 4-count capsules per carton, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 0911312397354.