D-1133-2017 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
2 bottles

Product Description

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

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

05092017@2B, 11/5/2017