FDA recall D-334-2013

Product

BLUE Diamond Pill, supplied in 1, 5 and 10 count blister packs, Male Sexual Enhancement, Distributed By: DH Distribution Los Angeles, CA 90026. 1 count blister: UPC 705105524764, 5 count blister: UPC 736211124012, 10 count blister: UPC 736211123916.

Reason for recall

Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2012-12-17

Report date

2013-05-22

Termination date

2013-11-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Commerce, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-334-2013