FDA recall D-0194-2019

Pharm D Solutions, LLC · Class II · drug

Product

Trimix QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine 1 mg/PGE 150 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1352-05

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2018-09-10
Report date
2018-11-07
Termination date
2021-02-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0194-2019