Gatifloxacin Ophthalmic Solution 0.5% recall: Labeling Error
Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth…
Why was Gatifloxacin Ophthalmic Solution 0.5% recalled?
Labeling: Incorrect or missing package insert.
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 #s: 289210F, Exp. 10/31/2019; 290632F, Exp. 10/31/2020
- Product
- Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth…
- Recalling firm
- Sandoz Inc
- Quantity
- 76,644 bottles
- Distribution
- Nationwide in the U.S.
- Recall date
- November 6, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)