Flucanazole Injection — Class III drug recall D-0605-2018
Terminated recall by Renaissance Lakewood, LLC, reported 2018-04-04, distributed nationwide. Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permea
| Recall number | D-0605-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Renaissance Lakewood, LLC, Lakewood, NJ, United States |
| Recall initiated | 2018-03-02 |
| Classified | 2018-03-23 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2020-04-10 |
| Distributed | Nationwide (US) |
| Quantity | 1,277 bags |
| Reason classes | potency, specification failure |
| NDC | 36000-0006-10 |
| Lot numbers | A060644 |
Product
Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India --- NDC 36000-006-10
Reason for recall
Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
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-0605-2018. 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.