Levofloxacin Ophthalmic Solution — Class III drug recall D-0514-2017
Terminated recall by Actavis Inc, reported 2017-03-15, distributed nationwide. Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month
| Recall number | D-0514-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Actavis Inc, Parsippany, NJ, United States |
| Recall initiated | 2017-02-07 |
| Classified | 2017-03-09 |
| Reported by FDA | 2017-03-15 |
| Terminated | 2018-01-09 |
| Distributed | Nationwide (US) |
| Quantity | 14,280 bottles |
| Reason classes | specification failure |
| NDC | 50383-0283-05 |
| Lot numbers | 348748, 350578, 633467 |
| Expiration dates | 2017-03-31, 2017-11-30, 2018-03-31 |
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 for recall
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
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-0514-2017. 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.