Ciprofloxacin in Dextrose (5%) Injection…

Date

Dec. 27, 2017

Risk class

Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)

Status

Terminated

Filed by

Claris Lifesciences Inc

Product

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

Superpotent

Distribution pattern

Nationwide

Codes and lots

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

Recall started

Nov. 6, 2017

Recall number

D-0127-2018

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0127-2018. The agency record governs; check it and the company before acting.