Medications & Supplements/Prescription Drugs

Promise Pharmacy LLC: Prednisolone and Gatifloxacin Ophthalmic Solution Recalled for Particulates

Agency Publication Date: October 25, 2018

Summary

Promise Pharmacy LLC is recalling one lot of Prednisolone and Gatifloxacin Ophthalmic Solution (1%/0.5%) eye drops. The recall was initiated because of the presence of a precipitate, which means solid particles or crystals have formed within the liquid solution. This prescription medication was distributed in 3 mL dropper bottles nationwide across the United States.

Risk

The presence of solid particles in an eye drop solution can cause irritation, inflammation, or physical damage to the delicate tissues of the eye when the drops are administered.

What You Should Do

Check your prescription eye drop bottle for Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, in a 3 mL dropper bottle.
Verify the lot number and expiration date on the label. This recall specifically affects Lot #: 04092018@2 with an expiration date of 12/03/2018.
If you have the affected medication, stop using it immediately to avoid potential eye irritation or injury.
Contact your healthcare provider or pharmacist for guidance regarding a replacement prescription and to report any adverse effects.
Return any unused portion of the recalled medication to the pharmacy where you purchased it for a refund.
Contact Promise Pharmacy LLC at their Palm Harbor, Florida location or through your prescribing clinic for further instructions.
For additional questions or to report a complaint, 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

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: Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5% (3 mL dropper bottle)

Lot Numbers:

04092018@2 (Exp 12/03/2018)

04092018

Date Ranges: Exp 12/03/2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81351

Status: Resolved

Manufacturer: Promise Pharmacy LLC

Sold By: Promise Pharmacy LLC

Manufactured In: United States

Distributed To: Nationwide

Agency Last Updated: November 8, 2018

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 prescription eye drop bottle for Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, in a 3 mL dropper bottle.

Verify the lot number and expiration date on the label. This recall specifically affects Lot #: 04092018@2 with an expiration date of 12/03/2018.

If you have the affected medication, stop using it immediately to avoid potential eye irritation or injury.

Contact your healthcare provider or pharmacist for guidance regarding a replacement prescription and to report any adverse effects.

Return any unused portion of the recalled medication to the pharmacy where you purchased it for a refund.

Contact Promise Pharmacy LLC at their Palm Harbor, Florida location or through your prescribing clinic for further instructions.

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