BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 47046...
FDA Recall #D-0247-2018 — Class I — November 29, 2017
Product Description
BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5
Reason for Recall
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.
Recalling Firm
Blue Fusion Natural — Orange, CA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
300 pill cards
Distribution
Nationwide
Code Information
All lots
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated