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Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, St...

FDA Recall #D-0265-2023 — Class III — January 30, 2023

Recall #D-0265-2023 Date: January 30, 2023 Classification: Class III Status: Ongoing

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

Reason for Recall

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

Recalling Firm

Akorn, Inc. — Gurnee, IL

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

45,117 Bottles

Distribution

Nationwide in the USA and Puerto Rico

Code Information

Lot: 081031A, Exp 2/28/2023

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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