FDA Drug recall D-1047-2017

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…

FDA Drug
Class II
terminated
Published 2017-08-09

On 2017-08-09 the FDA classified a Class II recall of 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… by Hospira A Pfizer, citing lack of Sterility Assurance.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-1047-2017
Classification	Class II
Status	terminated
Initiated	2017-06-15
Published	2017-08-09
Last updated	2026-09-13 11:51 UTC
Company	Hospira A Pfizer
Distribution	PR

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

Lack of Sterility Assurance

Identifiers

code_info	Lot: 72109EV Exp. 12/01/2018, Lot: 72110EV Exp. 12/01/2018, Lot: 72112EV Exp. 12/01/2018, Lot: 72113EV Exp. 12/01/2018… Lot: 72109EV Exp. 12/01/2018, Lot: 72110EV Exp. 12/01/2018, Lot: 72112EV Exp. 12/01/2018, Lot: 72113EV Exp. 12/01/2018, Lot: 72114EV Exp. 12/01/2018, Lot: 73068EV Exp. 01/01/2019, Lot: 73071EV Exp. 01/01/2019, Lot: 73072EV Exp. 01/01/2019, Lot: 73224EV Exp. 01/01/2019, Lot: 73225EV Exp. 01/01/2019, Lot: 73230EV Exp. 01/01/2019, Lot: 73231EV Exp. 01/01/2019, Lot: 73232EV Exp. 01/01/2019, Lot: 73233EV Exp. 01/01/2019, Lot: 73234EV Exp. 01/01/2019, Lot: 73235EV Exp. 01/01/2019, Lot: 73236EV Exp. 01/01/2019, Lot: 73298EV Exp. 01/01/2019, Lot: 74058EV Exp. 02/01/2019, Lot: 74104EV Exp. 02/01/2019, Lot: 74105EV Exp. 02/01/2019, Lot: 74106EV Exp. 02/01/2019, Lot; 74107EV Exp. 02/01/2019, Lot: 74197EV Exp. 02/01/2019, Lot: 74198EV Exp. 02/01/2019, Lot: 74199EV Exp. 02/01/2019, Lot: 74200EV Exp. 02/01/2019, Lot: 74201EV Exp. 02/01/2019, Lot: 75171EV Exp. 03/01/2019, Lot: 75172EV Exp. 03/01/2019, Lot: 75173EV Exp. 03/01/2019, Lot: 75174EV Exp. 03/01/2019, Lot: 75175EV Exp. 03/01/2019, Lot: 7517

code_info

Lot: 72109EV Exp. 12/01/2018, Lot: 72110EV Exp. 12/01/2018, Lot: 72112EV Exp. 12/01/2018, Lot: 72113EV Exp. 12/01/2018…

Lot: 72109EV Exp. 12/01/2018, Lot: 72110EV Exp. 12/01/2018, Lot: 72112EV Exp. 12/01/2018, Lot: 72113EV Exp. 12/01/2018, Lot: 72114EV Exp. 12/01/2018, Lot: 73068EV Exp. 01/01/2019, Lot: 73071EV Exp. 01/01/2019, Lot: 73072EV Exp. 01/01/2019, Lot: 73224EV Exp. 01/01/2019, Lot: 73225EV Exp. 01/01/2019, Lot: 73230EV Exp. 01/01/2019, Lot: 73231EV Exp. 01/01/2019, Lot: 73232EV Exp. 01/01/2019, Lot: 73233EV Exp. 01/01/2019, Lot: 73234EV Exp. 01/01/2019, Lot: 73235EV Exp. 01/01/2019, Lot: 73236EV Exp. 01/01/2019, Lot: 73298EV Exp. 01/01/2019, Lot: 74058EV Exp. 02/01/2019, Lot: 74104EV Exp. 02/01/2019, Lot: 74105EV Exp. 02/01/2019, Lot: 74106EV Exp. 02/01/2019, Lot; 74107EV Exp. 02/01/2019, Lot: 74197EV Exp. 02/01/2019, Lot: 74198EV Exp. 02/01/2019, Lot: 74199EV Exp. 02/01/2019, Lot: 74200EV Exp. 02/01/2019, Lot: 74201EV Exp. 02/01/2019, Lot: 75171EV Exp. 03/01/2019, Lot: 75172EV Exp. 03/01/2019, Lot: 75173EV Exp. 03/01/2019, Lot: 75174EV Exp. 03/01/2019, Lot: 75175EV Exp. 03/01/2019, Lot: 7517

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1047-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.