Medications & Supplements/Topical Products

Akorn Inc: Moisturizing Lubricant Eye Drops Recalled for Failed Stability Testing

Agency Publication Date: February 19, 2019

Summary

Akorn Inc. has recalled approximately 78,120 bottles of Walgreens Moisturizing Lubricant Eye Drops (sodium carboxymethylcellulose 0.25%). The recall was initiated because the product failed stability testing, specifically showing out-of-specification results for sodium perborate. These 0.5 fl oz (15mL) dropper bottles were distributed nationwide to Walgreens stores across the United States.

Risk

The eye drops failed stability specifications for sodium perborate, which may affect the product's quality or efficacy over time. Using a drug product that does not meet its chemical specifications could lead to ineffective treatment or potential irritation to the eye.

What You Should Do

Check your bottle of Walgreens Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose (0.5 Fl OZ / 15mL) for the following lot numbers and expiration dates: Lot 8D31A (Exp: 03/20), Lot 7H98A (Exp: 07/19), or Lot 7L80A (Exp: 10/19).
Verify the NDC number on the packaging is 00363-9651-01.
If your product matches the affected lot numbers, stop using the eye drops immediately.
Contact your healthcare provider or pharmacist for guidance regarding alternative treatments and return any unused product to the place of purchase for a refund.
Contact the manufacturer, Akorn Inc., at 1-847-279-6100 for further instructions regarding this recall.
For additional questions or to report a side effect, 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

Pharmacy refund and consultation

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

Affected Products

Product: Walgreens Moisturizing Lubricant Eye Drops (15mL)

Model:

NDC 00363-9651-01

Recall #: D-0511-2019

Lot Numbers:

8D31A (Exp: 03/20)

7H98A (Exp: 07/19)

7L80A (Exp: 10/19)

Date Ranges: Expiration: 03/2020, Expiration: 07/2019, Expiration: 10/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82177

Status: Resolved

Manufacturer: Akorn Inc

Sold By: Walgreens; Walgreen Co

Manufactured In: United States

Units Affected: 78120 dropper bottles

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

What You Should Do

Check your bottle of Walgreens Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose (0.5 Fl OZ / 15mL) for the following lot numbers and expiration dates: Lot 8D31A (Exp: 03/20), Lot 7H98A (Exp: 07/19), or Lot 7L80A (Exp: 10/19).

Verify the NDC number on the packaging is 00363-9651-01.

If your product matches the affected lot numbers, stop using the eye drops immediately.

Contact your healthcare provider or pharmacist for guidance regarding alternative treatments and return any unused product to the place of purchase for a refund.

Contact the manufacturer, Akorn Inc., at 1-847-279-6100 for further instructions regarding this recall.

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