FDA recall D-1049-2017

Product

Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vial (NDC 0409-6609-02), b.) 25 vial carton (NDC 0409-6609-25), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA

Reason for recall

Lack of Sterility Assurance

Distribution

U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore

Key facts

Status

Terminated

Initiation date

2017-06-15

Report date

2017-08-09

Termination date

2020-07-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rocky Mount, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1049-2017