U.S. flag An official website of the United States government
  1. Home
  2. Safety
  3. Recalls, Market Withdrawals, & Safety Alerts
  4. Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution
  1. Safety

COMPANY ANNOUNCEMENT

Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Read Announcement View Product Photos

Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution

Summary

Company Announcement Date:
October 22, 2018
FDA Publish Date:
October 22, 2018
Product Type:
Drugs
Prescription Drugs
Reason for Announcement:
Company Name:
Promise Pharmacy
Brand Name:
Brand Name(s)
Promise Pharmacy
Product Description:
Product Description
Prednisolone and Gatifloxacin Ophthalmic Solution

Company Announcement

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

To date 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.

The product is used as a post-surgical (cataract) ophthalmic treatment and was distributed Nationwide to individual patients.

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 and is arranging for return/replacement/refund of all recalled product

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 product to the pharmacy.

Prescribers and patients with questions regarding this recall can contact Promise Pharmacy at (727) 772-0500 x233 Monday through Friday between the hours of 9:00 am and 3:30 pm EST, 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 associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

 


Company Contact Information

Consumers:
Promise Pharmacy
(727) 772-0500 x233
mark@promisepharmacy.com

Product Photos