Medications & Supplements/Topical Products

Akorn, Inc.: Artificial Tears Lubricant Eye Ointment Recalled for Bacterial Contamination

Agency Publication Date: August 31, 2021

Summary

Akorn, Inc. is recalling 142,188 tubes of Artificial Tears Ointment (Lubricant Eye Ointment) because testing found the product was not sterile. The company discovered a bacterial contamination during stability testing, specifically identifying organisms from the Bacillus cereus group. This recall affects 3.5-gram tubes distributed across the United States and Puerto Rico.

Risk

The use of a non-sterile eye ointment contaminated with Bacillus cereus group bacteria can lead to serious eye infections, which could potentially result in vision loss or other severe health complications. No specific injuries have been reported to date, but the risk of infection is significant due to the product being applied directly to the eye.

What You Should Do

Check your Artificial Tears Ointment (3.5 g tubes) for the following Lot Numbers and Expiration Dates: Lot 9G01A (Exp 06/2022), Lot 9H32A (Exp 07/2022), and Lots 9K82A or 9K82B (Exp 09/2022).
Verify the NDC number on the packaging is 17478-062-35 to confirm it is the affected product.
If you have an affected tube, stop using it immediately to avoid the risk of bacterial infection.
Contact your healthcare provider or pharmacist for guidance regarding your eye health and to discuss alternative lubricant options.
Return any unused product to the pharmacy or place of purchase for a refund and contact Akorn, Inc. for further instructions.
For additional information or questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Artificial Tears Ointment, Lubricant Eye Ointment (Net Wt. 3.5 g)

Model:

NDC 17478-062-35

Recall #: D-0786-2021

Lot Numbers:

9G01A (Exp 06/2022)

9H32A (Exp 07/2022)

9K82A (Exp 09/2022)

9K82B (Exp 09/2022)

Date Ranges: Exp 06/2022, Exp 07/2022, Exp 09/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88594

Status: Resolved

Manufacturer: Akorn, Inc.

Sold By: Nationwide USA; Puerto Rico

Manufactured In: United States

Units Affected: 142,188 tubes

Distributed To: Nationwide

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

Risk

What You Should Do

Check your Artificial Tears Ointment (3.5 g tubes) for the following Lot Numbers and Expiration Dates: Lot 9G01A (Exp 06/2022), Lot 9H32A (Exp 07/2022), and Lots 9K82A or 9K82B (Exp 09/2022).

Verify the NDC number on the packaging is 17478-062-35 to confirm it is the affected product.

If you have an affected tube, stop using it immediately to avoid the risk of bacterial infection.

Contact your healthcare provider or pharmacist for guidance regarding your eye health and to discuss alternative lubricant options.

Return any unused product to the pharmacy or place of purchase for a refund and contact Akorn, Inc. for further instructions.

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