Medications & Supplements/Over-the-Counter

Clear Eyes Eye Allergy Itch Relief Recalled for Impurity Specification Failure

Agency Publication Date: March 16, 2023

Summary

Teva Pharmaceuticals USA Inc. has recalled approximately 715,632 bottles of Clear Eyes Once Daily Eye Allergy Itch Relief (olopatadine hydrochloride ophthalmic solution, USP, 0.2%). This recall was issued because the product failed stability testing due to an unspecified impurity that was found to be outside of required specifications. The antihistamine eye drops were sold in 2.5 mL (0.085 fl oz) sterile bottles at pharmacies and retailers nationwide.

Risk

The presence of an unspecified impurity that exceeds allowed levels could potentially cause irritation or reduce the effectiveness of the medication. No incidents or injuries have been reported to date.

What You Should Do

This recall affects Clear Eyes Once Daily Eye Allergy Itch Relief (olopatadine hydrochloride ophthalmic solution, USP, 0.2%) sold in 2.5 mL (0.085 fl oz) bottles with UPC 678112000708 and NDC 67172-504-01.
Check the lot number and expiration date printed on your bottle to see if it is included: 114349 (Exp. 05/2023), 117396 (Exp. 09/2023), 120128 (Exp. 11/2023), 114371 (Exp. 06/2023), or 123781 (Exp. 02/2024).
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Teva Pharmaceuticals USA Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Clear Eyes, Once Daily, Eye Allergy Itch Relief (2.5 mL)

Variants: olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine, Sterile

UPC Codes:

678112000708

Lot Numbers:

114349 (Exp. 05/2023)

117396 (Exp. 09/2023)

120128 (Exp. 11/2023)

114371 (Exp. 06/2023)

123781 (Exp. 02/2024)

NDC:

67172-504-01

Distributed by Medtech Products Inc. Tarrytown, NY 10591, A Prestige Consumer Healthcare company.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91757

Status: Resolved

Manufacturer: Teva Pharmaceuticals USA Inc

Sold By: pharmacies; retailers nationwide

Manufactured In: Israel, United States

Units Affected: 715,632 bottles

Distributed To: Nationwide

Agency Last Updated: March 20, 2023

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Clear Eyes Once Daily Eye Allergy Itch Relief (olopatadine hydrochloride ophthalmic solution, USP, 0.2%) sold in 2.5 mL (0.085 fl oz) bottles with UPC 678112000708 and NDC 67172-504-01.

Check the lot number and expiration date printed on your bottle to see if it is included: 114349 (Exp. 05/2023), 117396 (Exp. 09/2023), 120128 (Exp. 11/2023), 114371 (Exp. 06/2023), or 123781 (Exp. 02/2024).

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Teva Pharmaceuticals USA Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Clear Eyes, Once Daily, Eye Allergy Itch Relief (2.5 mL)

Variants: olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine, Sterile

UPC Codes:

678112000708

Lot Numbers:

114349 (Exp. 05/2023)

117396 (Exp. 09/2023)

120128 (Exp. 11/2023)

114371 (Exp. 06/2023)

123781 (Exp. 02/2024)

NDC:

67172-504-01

Distributed by Medtech Products Inc. Tarrytown, NY 10591, A Prestige Consumer Healthcare company.