Levofloxacin Injection in 5% Dextrose — Class II drug recall D-0615-2017
Terminated recall by Claris Lifesciences Inc, reported 2017-04-05, distributed nationwide. Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a
| Recall number | D-0615-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Claris Lifesciences Inc, North Brunswick, NJ, United States |
| Recall initiated | 2017-03-10 |
| Classified | 2017-03-24 |
| Reported by FDA | 2017-04-05 |
| Terminated | 2020-09-18 |
| Distributed | Nationwide (US) |
| Reason classes | sterility, packaging |
| NDC | 36000-0045, 36000-0045-01, 36000-0046, 36000-0046-24, 36000-0047, 36000-0047-24, 36000-0048, 36000-0048-24 |
| Lot numbers | A060040 |
| Expiration dates | 2017-12-20 |
Product
Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-048-24
Reason for recall
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
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-0615-2017. 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.