FDA recall D-1099-2020

Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy · Class II · drug

Product

Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530

Reason for recall

Lack of Assurance of Sterility

Distribution

Patient Distribution list includes addresses in the following states: CA, ME, TX

Key facts

Status: Terminated
Initiation date: 2020-03-26
Report date: 2020-04-15
Termination date: 2024-01-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Murrieta, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1099-2020