FDA Drug recall D-0163-2020
Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured by Alcon Laboratories, Inc
- FDA Drug
- Class III
- terminated
- Published 2019-11-06
On 2019-11-06 the FDA classified a Class III recall of Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured by Alcon Laboratories, Inc by Sandoz, citing labeling: Incorrect or missing package insert.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0163-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-10-17 |
| Published | 2019-11-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sandoz |
| Distribution | US |
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, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, Product of India, NDC 61314-672-25.
Reason
Labeling: Incorrect or missing package insert.
Identifiers
| ndc | 61314-672-25 |
|---|---|
| code_info | Lot #s: 289210F, Exp. 10/31/2019; 290632F, Exp. 10/31/2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0163-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.