FDA recall D-1096-2020

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

Product

MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B-12 6mcg/ml) , 10 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-1096-2020