D-0833-2023 Class II Ongoing

Recalled by Akorn, Inc. — Gurnee, IL

Recall Details

Product Type
Drugs
Report Date
June 7, 2023
Initiation Date
April 26, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Reason for Recall

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

Distribution Pattern

Nationwide in the USA and Puerto Rico

Code Information

All Lots