FDA recall D-1130-2017

ImprimisRx CA, Inc., dba ImprimisRx · Class II · drug

Product

Curcumin Emulsion 10mg/ml Injection, Sterile 10 mL Multiple Dose Vial, For Slow IV Administration, Compounded for a licensed professional or patient use by ImprimisRx, Irvine, CA

Reason for recall

Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2017-06-23
Report date
2017-09-13
Termination date
2019-01-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1130-2017