Fluconazole Injection — Class III drug recall D-1032-2018
Terminated recall by Renaissance Lakewood, LLC, reported 2018-08-08, distributed nationwide. Failed Stability Specifications: lot out of specification for elevated water vapor.
| Recall number | D-1032-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Renaissance Lakewood, LLC, Lakewood, NJ, United States |
| Recall initiated | 2018-07-11 |
| Classified | 2018-08-02 |
| Reported by FDA | 2018-08-08 |
| Terminated | 2022-03-09 |
| Distributed | Nationwide (US) |
| Quantity | 3,664 bags |
| Reason classes | specification failure |
| NDC | 36000-0002-10 |
| Lot numbers | 02/19, A0A0156 |
Product
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-002-10.
Reason for recall
Failed Stability Specifications: lot out of specification for elevated water vapor.
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-1032-2018. 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.