Sulfacetamide Sodium Ophthalmic Solution recalled over sterility concerns

Recall date

May 17, 2016

Source

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

Official notice title

Akorn, Inc. recalls Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest,…

Recall number

D-0949-2016

FDA classification

Class II

Brand / firm

Akorn, Inc.

Sold / distributed

Nationwide and Puerto Rico.

Why it was recalled

Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability

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

What was recalled

Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest, IL 60045 --- NDC 17478-221-12