FDA Drug recall D-0514-2017
Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville,…
- FDA Drug
- Class III
- terminated
- Published 2017-03-15
On 2017-03-15 the FDA classified a Class III recall of Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville,… by Actavis, citing failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0514-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-02-07 |
| Published | 2017-03-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Actavis |
| Distribution | US |
Product
Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY 11707, NDC 50383-283-05
Reason
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Identifiers
| code_info | Lot # 348748, Exp 11/30/2017; 350578, Exp 3/31/2018; 633467, Exp 3/31/2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0514-2017%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.