FDANovember 29, 2017drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

blue fusion naturalblueblue fusion

UPCs

847046009785

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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