Phenylephrine Hydrochloride Ophthalmic Solution recalled over sterility concerns

Recall date

September 20, 2019

Source

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

Official notice title

Akorn, Inc. recalls Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, I…

Recall number

D-1883-2019

FDA classification

Class II

Brand / firm

Akorn, Inc.

Sold / distributed

Nationwide in the USA and Puerto Rico

Why it was recalled

Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.

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

What was recalled

Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.