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 for: Lupin Pharmaceuticals, Inc.…
Why was Gatifloxacin Ophthalmic Solution 0.5% recalled?
Labeling: Missing label; Product complaints reported missing bottle label.
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 #: H805157, Exp. 05/2020
- Product
- Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for: Lupin Pharmaceuticals, Inc.…
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Quantity
- 17,238 bottles
- Distribution
- Nationwide in the U.S. and PR.
- Recall date
- July 24, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)