Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10...
FDA Recall #D-0124-2018 — Class III — November 11, 2017
Product Description
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
Recalling Firm
Renaissance Lakewood, LLC — Lakewood, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
24,569 bags
Distribution
Nationwide
Code Information
a) A060174 01/13/2018, A060257 02/28/2018, A060692 05/31/2018, A061165 09/30/2018, A0A0143 01/31/2019, A0A0347 03/31/2019, and A0A0424 04/30/2019 ; b) A060027 12/31/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated