Gatifloxacin Ophthalmic Solution 0 — Class III drug recall D-1848-2019
Terminated recall by Mylan Pharmaceuticals Inc., reported 2019-09-18, distributed nationwide. Failed Impurities/Degradation Specifications:OOS for unknown impurity.
| Recall number | D-1848-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc., Morgantown, WV, United States |
| Recall initiated | 2019-09-06 |
| Classified | 2019-09-09 |
| Reported by FDA | 2019-09-18 |
| Terminated | 2020-07-16 |
| Distributed | Nationwide (US) |
| Quantity | 13,157 |
| Reason classes | specification failure |
| NDC | 00378-5431-35 |
| Lot numbers | GABH0003 |
| Expiration dates | 2020-07 |
Product
Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. Made in India. NDC: 0378-5431-35
Reason for recall
Failed Impurities/Degradation Specifications:OOS for unknown impurity.
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-1848-2019. 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.