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

Recall Number: D-0949-2016

Firm: Akorn, Inc.

Classification: Class II

Status: Terminated

Report Date: 20160608

Initiation Date: 20160517

Termination Date: 20170721

Reason for Recall

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

Product Description

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