Drug Enforcement D-0265-2023

Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.

Status

Ongoing

Classification

Class III

Report Date

February 15, 2023

Termination Date

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Product Information

Product description
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
Product quantity
45,117 Bottles
Reason for recall
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA and Puerto Rico

Location & Firm

Recalling firm
Akorn, Inc.
Address
5605 Centerpoint Ct Ste A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0265-2023
Event ID
91580
Recall initiation date
January 30, 2023
Center classification date
February 8, 2023
Code info
Lot: 081031A, Exp 2/28/2023
More code info
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