FDA Recall: Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile

Promise Pharmacy is voluntarily recalling one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3ml vials, to the patient consumer level because the product has been found to have unidentified small particulate floating in the solution.

Promise Pharmacy has not received any reports of adverse events related to this recall. Potential adverse health consequences could range from limited eye irritation, inflammation, and visual impairment to permanent ocular damage with the use of this eye drop solution.

Lot Number 09042018@2, Exp. 12/03/2018 is the only affected lot.

Promise Pharmacy is notifying its prescribers and patients by telephone and mail. Patients who have product that is being recalled should stop using it and return it to Promise Pharmacy. Patients will be sent packaging with a prepaid shipping label to facilitate prompt return of the product to the pharmacy.

Prescribers and patients with questions regarding this recall may contact Promise Pharmacy at 727-772-0500, ext 233, Monday through Friday between the hours of 9:00 a.m. and 3:30 p.m. ET, or via email to mark@promisepharmacy.com. Patients should contact their prescribing physician if they have experienced any problems that may be related to using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by U.S. Mail, or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. If you have additional questions, please contact Jillian Winans, regulatory affairs specialist, at jwinans@ascrs.org or 703-591-2220.