Gatifloxacin Ophthalmic Solution 0 — Class III drug recall D-0163-2020
Terminated recall by Sandoz Inc, reported 2019-11-06, distributed nationwide. Labeling: Incorrect or missing package insert.
| Recall number | D-0163-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sandoz Inc, Princeton, NJ, United States |
| Recall initiated | 2019-10-17 |
| Classified | 2019-10-28 |
| Reported by FDA | 2019-11-06 |
| Terminated | 2022-01-19 |
| Distributed | Nationwide (US) |
| Quantity | 76,644 bottles |
| Reason classes | labeling |
| NDC | 61314-0672, 61314-0672-25 |
| Lot numbers | 289210F, 290632F |
| Expiration dates | 2019-10-31, 2020-10-31 |
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 for recall
Labeling: Incorrect or missing package insert.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0163-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.