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FDARecalled Jun 7, 2023 · #D-0783-2023

Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

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
Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Type
Drugs
Manufacturer
Akorn, Inc.
Model numbers
UPCs