Fluconazole Injection — Class III drug recall D-1033-2018
Terminated recall by Renaissance Lakewood, LLC, reported 2018-08-08, distributed nationwide. Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
| Recall number | D-1033-2018 |
|---|---|
| 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 | 12,088 bags |
| Reason classes | potency, specification failure |
| NDC | 36000-0002-06, 36000-0002-10 |
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 a) 36000-002-10 and b) 36000-002-06.
Reason for recall
Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
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-1033-2018. 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.