The Recall Desk

FDA (Drugs) recall action 77647

ImprimisRx CA, Inc., dba ImprimisRx recalled 4 products on 2017-09-13

The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2017-09-13
Critical
0
Units
2,645

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–4 of 4

  • ModerateFDA (Drugs)··2017-09-13

    ImprimisRx Recalls Latanoprost Ophthalmic Drops Due to Undeclared Excipient

    ImprimisRx is recalling 19 bottles of compounded Latanoprost ophthalmic drops because they contain non-pharmaceutical grade PEG 40 Castor Oil due to supplier mislabeling.

    Product
    Latanoprost PF Solution, 0.005%, Ophthalmic Drops in Sterile 5ml Bottles, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2017-09-13

    ImprimisRx Recalls Timolol-Latanoprost Ophthalmic Drops Due to Mislabeling

    ImprimisRx is recalling 16 bottles of compounded Timolol-Latanoprost ophthalmic drops because non-pharmaceutical grade PEG 40 Castor Oil was used due to supplier mislabeling.

    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
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-09-13

    ImprimisRx Recalls Timolol Ophthalmic Drops Due to Undeclared Excipient

    ImprimisRx is recalling compounded Timolol ophthalmic drops because they were made with non-pharmaceutical grade PEG 40 Castor Oil due to supplier mislabeling.

    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
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-09-13

    ImprimisRx Recalls Curcumin Emulsion Injection Due to Undeclared Excipient

    ImprimisRx is recalling Curcumin Emulsion 10mg/ml Injection vials because non-pharmaceutical grade PEG 40 Castor Oil was used due to supplier mislabeling.

    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
    Category
    Distribution
    0 states