D-0151-2023 Class II Ongoing

Recalled by Akorn, Inc. — Gurnee, IL

Recall Details

Product Type
Drugs
Report Date
January 25, 2023
Initiation Date
October 13, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
121,176 bottles

Product Description

Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 60429-957-05

Reason for Recall

CGMP Deviations:

Distribution Pattern

Nationwide in the USA

Code Information

Lot: 1C61A, EXP 2/28/2023; 1D86A, 1D07A, EXP 3/31/2023;