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 | Class II | 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 | Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier | ImprimisRx CA, Inc., dba ImprimisRx 9257 Research Dr Irvine, CA 92618-4286 | |
Latanoprost PF Solution, 0.005%, Ophthalmic Drops in Sterile 5ml Bottles, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA | Class II | 0404017@32B, 10/01/2017 | Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier | ImprimisRx CA, Inc., dba ImprimisRx 9257 Research Dr Irvine, CA 92618-4286 | |
Timolol-Latanoprost PF Solution (0.5-0.005)%, Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA | Class II | 04042017@34B, 10/01/2017 | Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier | ImprimisRx CA, Inc., dba ImprimisRx 9257 Research Dr Irvine, CA 92618-4286 | |
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 | Class II | 05092017@2B, 11/5/2017 | Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier | ImprimisRx CA, Inc., dba ImprimisRx 9257 Research Dr Irvine, CA 92618-4286 |
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Wednesday, September 13, 2017
September 13, 2017 FDA Enforcement Report
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