January 2023 FDA Recall Drug by Akorn, Inc.
D-0265-2023 - Failed Stability Specifications

This Class III drug recall was voluntarily initiated by Akorn, Inc. on January 30, 2023 for the product Drug. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0265-2023

Reason for Recall
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Initiated
01-30-2023
Reported
02-15-2023
Quantity
45,117 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91580
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Akorn, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# Lot: 081031A, Exp 2/28/2023