PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: September 13, 2017 Initiated: June 23, 2017 #D-1133-2017

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

Details

Units Affected
2 bottles
Distribution
Nationwide
Location
Irvine, CA

Frequently Asked Questions

What product was recalled?
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. Recalled by ImprimisRx CA, Inc., dba ImprimisRx. Units affected: 2 bottles.
Why was this product recalled?
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Which agency issued this recall?
This recall was issued by the FDA Drug on September 13, 2017. Severity: Moderate. Recall number: D-1133-2017.