FDA-Drug2018-04-04Class III
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
Renaissance Lakewood, LLC
Hazard
Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
Sold states
Nationwide
Affected count
1277 bags
Manufactured in
1200 Paco Way, Lakewood, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0605-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief