Home / Recalls / Renaissance Lakewood, LLC / D-1031-2018

D-1031-2018 Class III Terminated

Recalled by Renaissance Lakewood, LLC — Lakewood, NJ

Recall Details

Product Type
Drugs
Report Date
August 8, 2018
Initiation Date
July 11, 2018
Termination Date
March 9, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3000 bags

Product Description

Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India; NDC 36000-003-06.

Reason for Recall

Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot # A061213, Exp 09/18

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-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)
  • 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)