Product: Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bottles, and C) 15 mL bottles, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Reason for recall: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated: 20230426
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated