BLUE PEARL capsules recalled over undeclared sildenafil

Recall date

November 29, 2017

Source

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

Official notice title

Blue Fusion Natural recalls BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5

Recall number

D-0247-2018

FDA classification

Class I

Brand / firm

Blue Fusion Natural

Sold / distributed

Nationwide

Why it was recalled

Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.

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

BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5