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

FDA recall notice · announced February 7, 2018 · Blue Fusion Natural

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

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.

Notes

Distribution: Nationwide
Lot/code information: All lots
Quantity: 300 pill cards
Status: Terminated
Products in this recall event:
- BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5 (D-0247-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.