FDA recall D-453-2013

Product

Bimix Inj 30 :1 Syr, 12x1.5 ml syr, 10x1.2 ml syr, 2x2 ml syr, 2x1 ml syr, 12x.05 ml syr Penile Injection,30 and 90 day expiration,

Reason for recall

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-04-22

Report date

2013-06-05

Termination date

2014-08-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-453-2013