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D-0127-2018 Class III Terminated

Recalled by Claris Lifesciences Inc — North Brunswick, NJ

FDA drug recall D-0127-2018 was initiated by Claris Lifesciences Inc on November 6, 2017 and is designated Class III. Reason for recall: Superpotent The recall status is terminated (terminated April 20, 2020).

Recall Details

Product Type: Drugs
Report Date: December 27, 2017
Initiation Date: November 6, 2017
Termination Date: April 20, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity

Product Description

Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx Only, (2 mg/mL), 100 mL Flexible Bag, Manufactured for: Claris LifeScience Inc. North Brunswick NJ 08902 by Claris Injectables Ltd. Gujarat, India UPC 336000008242 NDC 36000-008-249

Reason for Recall

Superpotent

Distribution Pattern

Nationwide

Code Information

A060192 01/2018; A060305 02/2018; A061038 08/2018; A0A0068 12/2018; A0A0404 04/2019

Other recalls by Claris Lifesciences Inc

D-0614-2017 Class II — Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris (March 10, 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)