Home / Recalls / Renaissance Lakewood, LLC / D-0605-2018

D-0605-2018 Class III Terminated

Recalled by Renaissance Lakewood, LLC — Lakewood, NJ

Recall Details

Product Type
Drugs
Report Date
April 4, 2018
Initiation Date
March 2, 2018
Termination Date
April 10, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1277 bags

Product Description

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

Reason for Recall

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

Distribution Pattern

Nationwide

Code Information

Lot A060644, May 2018

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-0696-2018 Class II — Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 m (February 21, 2018)
  • D-0124-2018 Class III — Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (November 11, 2017)