FDA recall D-1023-2018

Product

Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-0106-01.

Reason for recall

Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.

Distribution

Nationwide in the USA and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2018-06-28

Report date

2018-08-08

Termination date

2022-08-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1023-2018