Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. NDC: 17478-215-02

Recall Number: D-0265-2023

Firm: Akorn, Inc.

Classification: Class III

Status: Ongoing

Report Date: 20230215

Initiation Date: 20230130

Termination Date:

Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.

Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. NDC: 17478-215-02