Class III · Lower riskRecall completed
Gatifloxacin
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot #s: 289210F, Exp. 10/31/2019; 290632F, Exp. 10/31/2020
Where it was soldNationwide in the U.S.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Labeling: Incorrect or missing package insert.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byAlcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, Product of India foreign manufacturer
| Brand name | GATIFLOXACIN |
| Generic name | GATIFLOXACIN |
| Active ingredient(s) | GATIFLOXACIN |
| Distributed by / for | Sandoz Inc |
| NDC | 61314-672-25 |
Show the full FDA record
| Full product label | 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, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, Product of India, NDC 61314-672-25. |
| Recalling firm | Sandoz Inc |
| Distribution | Nationwide in the U.S. |
| Quantity | 76,644 bottles |
| Recall initiated | 2019-10-17 |
| Report date | 2019-11-06 |
| Recall completed | 2022-01-19 |
| Recall number | D-0163-2020 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Princeton NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.