ImprimisRx CA, Inc., dba ImprimisRx: Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier

Agency Publication Date: September 7, 2017

Affected Products

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

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

Product: Latanoprost PF Solution, 0.005%, Ophthalmic Drops in Sterile 5ml Bottles, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA

0404017@32B, 10/01/2017

Product: Timolol-Latanoprost PF Solution (0.5-0.005)%, Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA

04042017@34B, 10/01/2017

Product: Timolol-Brimonidine-Dorzolamide-Latanoprost (0.5/0.15/2/0.005)% Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA

05092017@2B, 11/5/2017

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 77647

Status: Resolved

Manufacturer: ImprimisRx CA, Inc., dba ImprimisRx

Manufactured In: United States

Units Affected: 4 products (2608 vials; 19 bottles; 16 bottles; 2 bottles)

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Sources: FDA iRES · Raw API Response

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