# FDA recall D-1047-2017

> **Hospira a Pfizer Company** · Class II · drug recall initiated 2017-06-15.

## 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

- **Recall number:** D-1047-2017
- **Recalling firm:** Hospira a Pfizer Company
- **Classification:** Class II
- **Product type:** drug
- **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

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1047-2017

## Citation

> AI Analytics. FDA recall D-1047-2017. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-1047-2017. Source: US FDA. Licensed CC0.

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