Medications & Supplements/Prescription Drugs

Cipla Difluprednate Eye Drops Recalled for Potential Lack of Sterility

Agency Publication Date: July 20, 2022

Summary

Cipla has recalled 8,136 bottles of Difluprednate Ophthalmic Emulsion (difluprednate), 0.05%, due to a packaging defect. A broken protective cap can expose the dropper tip, which may compromise the sterility of the eye drops. One customer complaint has been received regarding this defect, although no injuries or infections have been reported to date.

Risk

A broken cap exposes the eye drop tip to environmental contaminants. Using non-sterile eye medication can lead to serious eye infections and other vision complications.

What You Should Do

This recall affects Cipla brand Difluprednate Ophthalmic Emulsion, 0.05% in 5ml bottles (NDC 69097-341-35) from batch DEG4LC2 with an expiration date of 05/2023.
If you have health concerns or experience unusual eye symptoms, contact your healthcare provider or pharmacist immediately.
Return any unused product to the place of purchase for a refund, throw it away, or contact Cipla for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

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: Difluprednate Ophthalmic Emulsion (5ml)

Variants: 0.05%, Rx only

Lot Numbers:

DEG4LC2 (Exp 05/2023)

NDC:

69097-341-35

Recall #: D-1283-2022. Total quantity affected: 8,136 bottles.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90608

Status: Resolved

Manufacturer: CIPLA

Sold By: pharmacies; healthcare providers

Manufactured In: India, United States

Units Affected: 8,136 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

This recall affects Cipla brand Difluprednate Ophthalmic Emulsion, 0.05% in 5ml bottles (NDC 69097-341-35) from batch DEG4LC2 with an expiration date of 05/2023.

If you have health concerns or experience unusual eye symptoms, contact your healthcare provider or pharmacist immediately.

Return any unused product to the place of purchase for a refund, throw it away, or contact Cipla for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.