Medications & Supplements/Prescription Drugs

Cequa Ophthalmic Solution Recalled for Low Potency and Particles

Agency Publication Date: April 7, 2022

Summary

SUN PHARMACEUTICAL INDUSTRIES INC is recalling 73,030 boxes of Cequa (cyclosporine ophthalmic solution) 0.09% because some vials were found to have lower drug potency than required and may contain particulate matter. This recall affects single-use vials packaged in boxes of 60. Consumers should contact their healthcare provider or pharmacist regarding the use of this medication.

Risk

The drug may be less effective due to low potency, and the presence of particulate matter in an eye solution could cause irritation or injury to the eye. No incidents or injuries have been reported to date.

What You Should Do

This recall affects Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches containing 10 single-use vials (0.25 mL each) per box.
Check your medication packaging for NDC 47335-506-96 and lot numbers 10014 or 10016 with an expiration date of 08/2022.
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 the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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: Cequa (cyclosporine ophthalmic solution) 0.09% (73,030 boxes)

Variants: 0.09% concentration, Single-use vials (0.25 mL)

Lot Numbers:

10014 (Exp 08/2022)

10016 (Exp 08/2022)

NDC:

47335-506-96

Packaged in 6 pouches x 10 single-use vials per box; Manufactured for Sun Pharma Global FZE by Laboratoire Unither in France.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89917

Status: Resolved

Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC

Sold By: Pharmacies; Healthcare providers

Manufactured In: United States, France

Units Affected: 73,030 boxes

Distributed To: Nationwide

Agency Last Updated: April 14, 2022

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 Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches containing 10 single-use vials (0.25 mL each) per box.

Check your medication packaging for NDC 47335-506-96 and lot numbers 10014 or 10016 with an expiration date of 08/2022.

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 the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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: Cequa (cyclosporine ophthalmic solution) 0.09% (73,030 boxes)

Variants: 0.09% concentration, Single-use vials (0.25 mL)

Lot Numbers:

10014 (Exp 08/2022)

10016 (Exp 08/2022)

NDC:

47335-506-96

Packaged in 6 pouches x 10 single-use vials per box; Manufactured for Sun Pharma Global FZE by Laboratoire Unither in France.