Home / Recalls / Claris Lifesciences Inc / D-0614-2017

D-0614-2017 Class II Terminated

Recalled by Claris Lifesciences Inc — North Brunswick, NJ

Recall Details

Product Type
Drugs
Report Date
April 5, 2017
Initiation Date
March 10, 2017
Termination Date
September 18, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
18,096 units (3016 cartons x 6 bags)

Product Description

Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-003-06

Reason for Recall

Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.

Distribution Pattern

Nationwide

Code Information

Lot #: A051052, Exp. Aug 2017

Other recalls by Claris Lifesciences Inc

  • D-0127-2018 Class III — Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx (November 6, 2017)
  • D-0616-2017 Class II — Metronidazole Injection, USP, 500 mg/100 mL, Rx only, Manufactured for: Claris L (March 10, 2017)
  • D-0613-2017 Class II — Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, Rx (March 10, 2017)
  • D-0615-2017 Class II — Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only, M (March 10, 2017)