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FDARecalled Jun 7, 2023 · #D-0779-2023

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 Operatin...

Hazard

Class II — temporary health risk

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Description

CGMP Deviations: Firm went out of business and could no longer continue stability studies. Classification: Class II Distribution: Nationwide in the USA and Puerto Rico

Product details

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
Type
Drugs
Manufacturer
Akorn, Inc.
Model numbers
UPCs