Medications & Supplements/Topical Products

Avella of Deer Valley, Inc. Store 38: Povidone Iodine Ophthalmic Solution Recalled for Lack of Sterility Assurance

Agency Publication Date: October 18, 2019

Summary

Avella of Deer Valley, Inc. Store 38 is recalling 808 droptainers of Povidone Iodine 5% Ophthalmic Solution (povidone-iodine), an antiseptic eye drop. The recall was initiated because the product lacks sterility assurance, meaning the solution may not be free from microorganisms. While no specific injuries have been reported, using a non-sterile eye product can lead to serious eye infections.

Risk

If an ophthalmic solution is contaminated or lacks sterility assurance, it can introduce bacteria or other pathogens directly into the eye. This poses a significant risk of infection, which can lead to inflammation, irritation, or potentially more severe vision-related complications.

What You Should Do

Check your medicine cabinet for 5 mL droptainers of Povidone Iodine, 5% Ophthalmic Solution labeled as repackaged by Avella Specialty Pharmacy with NDC 42852-006-20.
Verify if your product matches Lot # 138-20190205@3 with an expiration date of 10/29/2019, or Lot # 138-20190705@7 with an expiration date of 11/3/2019.
Immediately stop using the affected eye drops if they match the recalled lot numbers and expiration dates.
Contact your healthcare provider or pharmacist for guidance regarding your treatment and any potential symptoms of infection.
Return any unused product to the pharmacy where it was purchased for a refund and contact Avella of Deer Valley, Inc. Store 38 for further instructions.
For additional 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

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

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

Affected Products

Product: Povidone Iodine, 5% Ophthalmic Solution (5 mL)

Model:

NDC 42852-006-20

Recall #: D-0152-2020

Lot Numbers:

138-20190205@3 (Exp . Date 10/29/2019)

138-20190705@7 (Exp. Date 11/3/2019)

138-20190205

Date Ranges: Expiration Date 10/29/2019, Expiration Date 11/3/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83833

Status: Resolved

Manufacturer: Avella of Deer Valley, Inc. Store 38

Sold By: Avella Specialty Pharmacy

Manufactured In: United States

Units Affected: 808 droptainers

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 medicine cabinet for 5 mL droptainers of Povidone Iodine, 5% Ophthalmic Solution labeled as repackaged by Avella Specialty Pharmacy with NDC 42852-006-20.

Verify if your product matches Lot # 138-20190205@3 with an expiration date of 10/29/2019, or Lot # 138-20190705@7 with an expiration date of 11/3/2019.

Immediately stop using the affected eye drops if they match the recalled lot numbers and expiration dates.

Contact your healthcare provider or pharmacist for guidance regarding your treatment and any potential symptoms of infection.

Return any unused product to the pharmacy where it was purchased for a refund and contact Avella of Deer Valley, Inc. Store 38 for further instructions.

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