Travoprost Ophthalmic Solution USP recalled over sterility concerns

Recall date

October 5, 2016

Source

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

Official notice title

Par Pharmaceutical, Inc. recalls Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx only, FOR USE IN THE EYES ONLY, Made in I…

Recall number

D-0154-2017

FDA classification

Class II

Brand / firm

Par Pharmaceutical, Inc.

Sold / distributed

Nationwide

Why it was recalled

Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container

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

What was recalled

Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx only, FOR USE IN THE EYES ONLY, Made in India, Distributed by: Par Pharmaceutical Cos., Inc, Spring Valley, NY 10977