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Olopatadine HCl, Ophthalmic Solution, USP, 0.2%, 2.5 mL per dropper bottle, Rx Only, Manufactured...

FDA Recall # — Class III — June 3, 2022

Recall # Date: June 3, 2022 Classification: Class III Status: Terminated

Product Description

Olopatadine HCl, Ophthalmic Solution, USP, 0.2%, 2.5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-305-12

Reason for Recall

Failed impurity/degradation specifications: Out of specification for 2-HMP (a product leachable) measured in retention samples

Recalling Firm

Akorn, Inc. — Lake Forest, IL

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

111,304 bottles

Distribution

Nationwide USA

Code Information

Lot#: 1D90A, 1D92A, Exp 3/2023; 1E30A, Exp 4/2023

Status

Terminated

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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