D-1130-2017 Class II Terminated

Recalled by ImprimisRx CA, Inc., dba ImprimisRx — Irvine, CA

Recall Details

Product Type
Drugs
Report Date
September 13, 2017
Initiation Date
June 23, 2017
Termination Date
January 14, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2608 vials

Product Description

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 Pattern

Nationwide

Code Information

03212017@21B Exp:6/19/2017; 03232017@19B Exp:6/21/2017; 03292017@27B Exp:6/27/2017; 03292017@9B Exp:6/27/2017; 04042017@21B Exp:7/3/2017; 04122017@22B Exp:7/11/2017; 04132017@14B Exp:7/12/2017; 04192017@37B Exp:7/18/2017; 04192017@17B Exp:7/18/2017; 04242017@18B Exp:7/23/2017