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Recall Observatory FDA recall evidence

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

D-1130-2017

June 23, 2017

Class II

Product summary

Firm
ImprimisRx CA, Inc., dba ImprimisRx
Event
Event 77647
Status
Terminated
Classification
Class II
Quantity
2608 vials
Official record key
drug-enforcement:D-1130-2017

Official wording

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

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

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeling