Timolol-Latanoprost PF Solution % recalled over undeclared excipient

Recall date

June 23, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

ImprimisRx CA, Inc., dba ImprimisRx recalls Timolol-Latanoprost PF Solution (0.5-0.005)%, Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professio…

Recall number

D-1132-2017

FDA classification

Class II

Brand / firm

ImprimisRx CA, Inc., dba ImprimisRx

Sold / distributed

Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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