FDA-Drug2023-02-15Class III
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
Akorn, Inc.
Hazard
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Sold states
Nationwide in the USA and Puerto Rico
Affected count
45,117 Bottles
Manufactured in
5605 Centerpoint Ct Ste A, Gurnee, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0265-2023Don't want to check this manually?
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