FDA recall D-0247-2018

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-11-29

Report date

2018-02-07

Termination date

2018-12-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Orange, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0247-2018