Medications & Supplements/Prescription Drugs

Akorn Inc: COSOPT Ophthalmic Solution Recalled Due to Failed Stability Specifications

Agency Publication Date: February 8, 2019

Summary

Akorn Inc. has recalled 30,794 bottles of COSOPT (dorzolamide hydrochloride and timolol maleate) Ophthalmic Solution, USP, 2%/0.5% in 10 mL dropper bottles. This prescription eye medication was found to be out of specification for 'opalescence' during a 7-month stability study, meaning the liquid may not be as clear as required. These affected bottles were distributed nationwide in the USA and Puerto Rico.

Risk

A failed stability test for opalescence indicates that the medication's physical properties have changed over time, which could potentially affect the drug's effectiveness or consistency. While the risk level is considered low, using a solution that does not meet clear appearance standards may not provide the intended therapeutic results.

What You Should Do

Check your prescription eye drop bottle to see if it is COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate) in a 10 mL dropper bottle.
Locate the NDC number 17478-605-10 and check the lot numbers and expiration dates on the packaging.
If your bottle belongs to lot 426007 or 426008 with an expiration date of 4/2020, you should identify it as part of this recall.
Contact your healthcare provider or pharmacist immediately to discuss using an alternative supply and for guidance on your treatment.
Return any unused product from the affected lots to your pharmacy for a refund and contact Akorn, Inc. for further instructions.
For additional questions or to report a problem, 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: COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate) (10 mL)

Model:

NDC: 17478-605-10

Lot Numbers:

426007 (Exp 4/2020)

426008 (Exp 4/2020)

Date Ranges: Expiration date: 4/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81836

Status: Resolved

Manufacturer: Akorn Inc

Manufactured In: United States

Units Affected: 30,794 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

Risk

What You Should Do

Check your prescription eye drop bottle to see if it is COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate) in a 10 mL dropper bottle.

Locate the NDC number 17478-605-10 and check the lot numbers and expiration dates on the packaging.

If your bottle belongs to lot 426007 or 426008 with an expiration date of 4/2020, you should identify it as part of this recall.

Contact your healthcare provider or pharmacist immediately to discuss using an alternative supply and for guidance on your treatment.

Return any unused product from the affected lots to your pharmacy for a refund and contact Akorn, Inc. for further instructions.

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