Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution
- Company Announcement Date:
- October 22, 2018
- FDA Publish Date:
- March 18, 2019
- Product Type:
- Reason for Announcement:
Recall ReasonDevice & Drug Safety
- Company Name:
- Promise Pharmacy
- Brand Name:
Brand Name(s)Promise Pharmacy
- Product Description:
Product DescriptionPrednisolone and Gatifloxacin Ophthalmic Solution
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 firstname.lastname@example.org. 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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
Company Contact Information
- Promise Pharmacy
- (727) 772-0500 x233