FDA-Drug2017-12-27Class III

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

Renaissance Lakewood, LLC
Hazard

Superpotent

Sold states
Nationwide
Affected count
24,569 bags
Manufactured in
1200 Paco Way, Lakewood, NJ, United States
Products
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

Official notice

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

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