FDA recall D-1047-2017

Product

8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA, NDC: 0409-6625-02

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-1047-2017