US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Apr 26, 2023 (3 years ago)

Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

What was recalled

Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile, For Topical Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Recalling firm
Akorn, Inc.
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0784-2023

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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