Medications & Supplements/Prescription Drugs

Gatifloxacin Ophthalmic Solution Recalled for Potential Altered Concentration

Agency Publication Date: October 22, 2021

Summary

Lupin Pharmaceuticals Inc. has voluntarily recalled 16,272 bottles of Gatifloxacin Ophthalmic Solution (0.5%), a prescription antibiotic eye drop. The recall was initiated because the medication may have an altered concentration of the active ingredient due to water loss during storage. No incidents or injuries have been reported to date in connection with this issue.

Risk

A change in drug concentration could potentially affect the medication's effectiveness or cause unintended irritation to the eye when applied. Consumers using this product should consult with a healthcare professional regarding their treatment.

What You Should Do

This recall involves 2.5 mL bottles of Gatifloxacin Ophthalmic Solution, 0.5%, with NDC number 68180-435-01 and lot number H002512 (expiration date March 2022).
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Lupin Pharmaceuticals Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Gatifloxacin Ophthalmic Solution, 0.5% (2.5 mL bottle)

Variants: 0.5%, 2.5 mL bottle, Rx only

Lot Numbers:

H002512 (Exp March 2022)

NDC:

68180-435-01

Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88885

Status: Resolved

Manufacturer: Lupin Pharmaceuticals Inc.

Sold By: pharmacies

Manufactured In: India, United States

Units Affected: 16,272 bottles

Distributed To: Nationwide

Agency Last Updated: November 2, 2021

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

This recall involves 2.5 mL bottles of Gatifloxacin Ophthalmic Solution, 0.5%, with NDC number 68180-435-01 and lot number H002512 (expiration date March 2022).

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Lupin Pharmaceuticals Inc. for further instructions.

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

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.