FDA Drug Class III — Least Serious

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

Hazard

Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability

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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.
Brand
Renaissance Lakewood, LLC
UPC
Lot A060644, May 2018

Units Affected

1277 bags

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