Medications & Supplements/Prescription Drugs

LEADIANT BIOSCIENCES, INC: Cystaran (cysteamine) Ophthalmic Solution Recalled for Subpotency

Agency Publication Date: April 17, 2018

Summary

Leadiant Biosciences, Inc. is recalling 3,398 bottles of Cystaran (cysteamine ophthalmic solution) 0.44% because the medication was found to be subpotent. This means the drug does not contain the required amount of the active ingredient, cysteamine hydrochloride, to be fully effective. The affected 15 mL bottles were distributed through Walgreens Specialty Pharmacy in Pittsburgh and internationally to Italy and Germany.

Risk

If the medication is subpotent, patients may not receive the full therapeutic dose intended by their doctor. This could result in the treatment being less effective or failing to manage the condition as expected.

What You Should Do

Check your medication bottle to see if it is Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, with NDC 54482-020-01.
Look for lot number 35866 with an expiration date of 6/18 or lot number 358663 with an expiration date of 7/18 on the packaging.
Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if you need a replacement prescription.
Return any unused product from these specific lots to the pharmacy where you purchased it to receive a refund.
Contact Leadiant Biosciences, Inc. at their headquarters in Gaithersburg, Maryland, for further instructions regarding this recall.
For additional questions or to report a problem, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Pharmacy refund and healthcare consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Cystaran (cysteamine ophthalmic solution) 0.44% (15 mL bottle)

Model:

NDC 54482-020-01

Recall #: D-0683-2018

Lot Numbers:

35866 (Exp 6/18)

358663 (Exp 7/18)

Date Ranges: Exp 6/18, Exp 7/18

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79849

Status: Resolved

Manufacturer: LEADIANT BIOSCIENCES, INC

Sold By: Walgreens Specialty Pharmacy

Manufactured In: United States

Units Affected: 3,398 bottles

Distributed To: Pennsylvania

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 medication bottle to see if it is Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, with NDC 54482-020-01.

Look for lot number 35866 with an expiration date of 6/18 or lot number 358663 with an expiration date of 7/18 on the packaging.

Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if you need a replacement prescription.

Return any unused product from these specific lots to the pharmacy where you purchased it to receive a refund.

Contact Leadiant Biosciences, Inc. at their headquarters in Gaithersburg, Maryland, for further instructions regarding this recall.

For additional questions or to report a problem, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA).