Akorn, Inc. recalls Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by:…

Recall date

December 26, 2019

Source

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

Recall number

D-1388-2020

FDA classification

Class III

Brand / firm

Akorn, Inc.

Sold / distributed

Nationwide USA and Puerto Rico

Why it was recalled

Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-263-12