# FDA recall D-0696-2018

> **Renaissance Lakewood, LLC** · Class II · drug recall initiated 2018-02-21.

## 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.

## Distribution

Product was distributed throughout the United States.

## Key facts

- **Recall number:** D-0696-2018
- **Recalling firm:** Renaissance Lakewood, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-02-21
- **Report date:** 2018-04-25
- **Termination date:** 2019-08-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lakewood, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0696-2018

## Citation

> AI Analytics. FDA recall D-0696-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0696-2018. Source: US FDA. Licensed CC0.

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