FDA recall D-1339-2019

Product

Trimix 30mg/1 mg/10mcg/mL ( 30 mg Papaverine, 1mg phentolamine mesylate, 30 mcg alprostadil) Injectable, 5mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846

Reason for recall

Lack of Sterility Assurance.

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2019-05-23

Report date

2019-06-19

Termination date

2021-02-05

Voluntary/Mandated

FDA Mandated

Location

Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1339-2019