FDAClass IIIOctober 31, 2018

Prednisolone and Gatifloxacin Ophthalmic Solution recall

Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684

Why was Prednisolone and Gatifloxacin Ophthalmic Solution recalled?

Presence of precipitate

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot#: 04092018@2, Exp 12/03/2018

Product
Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684
Recalling firm
Promise Pharmacy LLC
Quantity
N/A
Distribution
U.S.A. Nationwide.
Recall date
October 31, 2018
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls