LATANOPROST OPHTHALMIC SOLUTION recalled over sterility concerns

Recall date

March 17, 2017

Source

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

Official notice title

Akorn, Inc. recalls LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bottle, Rx only, Manufactured for: Akorn, In…

Recall number

D-0661-2017

FDA classification

Class II

Brand / firm

Akorn, Inc.

Sold / distributed

Nationwide

Why it was recalled

Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.

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

What was recalled

LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-625-12