Blue Fusion Natural recalls BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5
Recalled February 7, 2018 · FDA recall D-0247-2018 · Blue Fusion Natural
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. · FDA Class I
Units
300 pill cards
Sold at
Nationwide
Description
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.
Product
BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5
Manufacturer(s)
Blue Fusion Natural
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →