Home / Recalls / Renaissance Lakewood, LLC / D-0124-2018

D-0124-2018 Class III Terminated

Recalled by Renaissance Lakewood, LLC — Lakewood, NJ

Recall Details

Product Type
Drugs
Report Date
December 27, 2017
Initiation Date
November 11, 2017
Termination Date
April 1, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
24,569 bags

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

Distribution Pattern

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

Other recalls by Renaissance Lakewood, LLC

  • D-1033-2018 Class III — Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 m (July 11, 2018)
  • D-1032-2018 Class III — Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 m (July 11, 2018)
  • D-1031-2018 Class III — Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 m (July 11, 2018)
  • D-0605-2018 Class III — Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexibl (March 2, 2018)
  • D-0696-2018 Class II — Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 m (February 21, 2018)