Fluconazole Injection — Class II drug recall D-0696-2018
Terminated recall by Renaissance Lakewood, LLC, reported 2018-04-25, distributed nationwide. Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmotic Sodium Chlo
| Recall number | D-0696-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Renaissance Lakewood, LLC, Lakewood, NJ, United States |
| Recall initiated | 2018-02-21 |
| Classified | 2018-04-24 |
| Reported by FDA | 2018-04-25 |
| Terminated | 2019-08-14 |
| Distributed | Nationwide (US) |
| Quantity | 1,784 bags |
| Reason classes | labeling |
| NDC | 36000-0002-10 |
| Lot numbers | 05/19, A0A0539 |
Product
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), package in 100 mL bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902, By: Claris Injectables Limited, Sarkhei-Bavla Road, Chacharwadi-Vasna, Ahmedabad, India 382213, NDC 36000-002-10
Reason for recall
Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmotic Sodium Chloride Diluent, USP, 2mg/mL, 50 mL found within the package of 100 mL bags.
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-0696-2018. 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.