# FDA recall D-1031-2018

> **Renaissance Lakewood, LLC** · Class III · drug recall initiated 2018-07-11.

## Product

Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India; NDC 36000-003-06.

## Reason for recall

Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1031-2018
- **Recalling firm:** Renaissance Lakewood, LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-07-11
- **Report date:** 2018-08-08
- **Termination date:** 2022-03-09

- **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-1031-2018

## Citation

> AI Analytics. FDA recall D-1031-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-1031-2018. Source: US FDA. Licensed CC0.

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