FDA recall D-0124-2018

Renaissance Lakewood, LLC · Class III · drug

Product

Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only, Manufactured for: Claris LifeSciences, Inc. North Brunswick, NJ 08902 By: Claris Injectables Ltd., Gujarat, India

Reason for recall

Superpotent

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2017-11-11
Report date: 2017-12-27
Termination date: 2020-04-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lakewood, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0124-2018