Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

ISSUE: FDA is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects. 

Date Initiated by Firm: December 14, 2017

Create Date: March 20, 2018

Recall Status1:Open3, Classified

Recall Number: Z-1278-2018

Recall Event ID: 79478

The Centers for Medicare & Medicaid Services has contracted with the RELI Group to conduct the upcoming ESRD QIP Data Validity and Reliability Study.