FDA Drug recall D-0436-2020
Ofloxacin Ophthalmic Solution, USP, 0.3%, 5 mL, Rx only, Altaire Pharmaceuticals, Inc., NDC 59390-140-05
- FDA Drug
- Class II
- completed
- Published 2019-11-27
On 2019-11-27 the FDA classified a Class II recall of Ofloxacin Ophthalmic Solution, USP, 0.3%, 5 mL, Rx only, Altaire Pharmaceuticals, Inc., NDC 59390-140-05 by Altaire Pharmaceuticals, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0436-2020 |
| Classification | Class II |
| Status | completed |
| Initiated | 2019-07-02 |
| Published | 2019-11-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Altaire Pharmaceuticals |
| Distribution | US |
Product
Ofloxacin Ophthalmic Solution, USP, 0.3%, 5 mL, Rx only, Altaire Pharmaceuticals, Inc., NDC 59390-140-05
Reason
Lack of Assurance of Sterility
Identifiers
| ndc | 59390-140-05 |
|---|---|
| code_info | 17244 8/19 18057 3/20 518307 12/20 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0436-2020%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.