Home / Recalls / ImprimisRx CA, Inc., dba ImprimisRx / D-1132-2017

D-1132-2017 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
16 bottles

Product Description

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

04042017@34B, 10/01/2017

Other recalls by ImprimisRx CA, Inc., dba ImprimisRx

  • D-1130-2017 Class II — Curcumin Emulsion 10mg/ml Injection, Sterile 10 mL Multiple Dose Vial, For Slow (June 23, 2017)
  • D-1131-2017 Class II — Latanoprost PF Solution, 0.005%, Ophthalmic Drops in Sterile 5ml Bottles, Compou (June 23, 2017)
  • D-1133-2017 Class II — Timolol-Brimonidine-Dorzolamide-Latanoprost (0.5/0.15/2/0.005)% Ophthalmic Drops (June 23, 2017)