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Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Re...

FDA Recall #D-0150-2023 — Class II — October 13, 2022

Recall #D-0150-2023 Date: October 13, 2022 Classification: Class II Status: Ongoing

Product Description

Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 51407-499-05

Reason for Recall

CGMP Deviations:

Recalling Firm

Akorn, Inc. — Gurnee, IL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

163,996 bottles

Distribution

Nationwide in the USA

Code Information

Lot: 1L16A, 1L17A, EXP 10/31/2023; 1M29A, EXP 11/30/2023; 2A05A, EXP 12/31/2023;

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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