FDA recall D-0605-2018

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2018-03-02

Report date

2018-04-04

Termination date

2020-04-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lakewood, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0605-2018