Home / Recalls / Akorn, Inc. / D-0577-2018

D-0577-2018 Class III Terminated

Recalled by Akorn, Inc. — Lake Forest, IL

Recall Details

Product Type
Drugs
Report Date
March 14, 2018
Initiation Date
February 21, 2018
Termination Date
August 31, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
31,812 bottles

Product Description

Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05

Reason for Recall

Failed Stability Specification: OOS low viscosity results discovered during retain testing.

Distribution Pattern

Nationwide in the USA

Code Information

Lot: 011037A

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