Medications & Supplements/Prescription Drugs

Akorn, Inc.: Proparacaine Hydrochloride Ophthalmic Solution Recalled for Contamination

Agency Publication Date: July 14, 2020

Summary

Akorn, Inc. is recalling 33,343 bottles of Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5% (15 mL), a sterile prescription eye drop used for numbing the eye. This voluntary recall was initiated because equipment cleaning residue rinse samples showed results that were out of specification, indicating a risk of chemical contamination. Consumers should be aware that this affects bottles from Lot 9E52A distributed throughout the United States and Puerto Rico.

Risk

The product may be contaminated with chemical residue from the manufacturing equipment. Using contaminated eye drops can lead to irritation, chemical burns, or other adverse reactions in the sensitive tissues of the eye.

What You Should Do

Check your supply of eye drops to see if you have the affected product: Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5% in a 15 mL dropper bottle (NDC 17478-263-12).
Look for Lot number 9E52A with an expiration date of 04/2021 on the bottle label to confirm if your medication is part of this recall.
Immediately contact your healthcare provider or pharmacist for guidance regarding your treatment and to obtain a safe replacement.
Return any unused bottles from the affected lot to the pharmacy or place of purchase for a refund.
Contact Akorn, Inc. at 1-888-723-3332 for further instructions on how to return the product or for more information regarding the recall.
Report any adverse reactions or quality problems to the FDA's MedWatch Adverse Event Reporting program at 1-888-SAFEFDA (1-888-723-3332) or online at 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: Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5% (15 mL)

Model:

NDC 17478-263-12

Recall #: D-1388-2020

Lot Numbers:

9E52A (Exp 04/2021)

Date Ranges: Expiration Date: 04/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86019

Status: Resolved

Manufacturer: Akorn, Inc.

Sold By: Pharmacies; Hospitals

Manufactured In: United States

Units Affected: 33,343 bottles

Distributed To: Nationwide

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 supply of eye drops to see if you have the affected product: Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5% in a 15 mL dropper bottle (NDC 17478-263-12).

Look for Lot number 9E52A with an expiration date of 04/2021 on the bottle label to confirm if your medication is part of this recall.

Immediately contact your healthcare provider or pharmacist for guidance regarding your treatment and to obtain a safe replacement.

Return any unused bottles from the affected lot to the pharmacy or place of purchase for a refund.

Contact Akorn, Inc. at 1-888-723-3332 for further instructions on how to return the product or for more information regarding the recall.

Report any adverse reactions or quality problems to the FDA's MedWatch Adverse Event Reporting program at 1-888-SAFEFDA (1-888-723-3332) or online at www.fda.gov/safety/recalls.