Akorn, Inc. recalls Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distrib
Recalled February 15, 2023 · FDA recall D-0265-2023 · Akorn
Hazard
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint. · FDA Class III
Units
45,117 Bottles
Sold at
Nationwide in the USA and Puerto Rico
Description
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Product
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
Manufacturer(s)
Akorn, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →