# FDA recall D-1279-2022

> **Nephron Sterile Compounding Center LLC** · Class II · drug recall initiated 2022-06-30.

## Product

8.4% Sodium Bicarbonate Injection, USP, 4.2 g/50 mL (84 mg/mL) 1 mEq/mL syringe, packaged in 1 x 50 mL Pre-Filled Syringe per carton, 30 x 1 syringe carton per case, Rx Only Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-214-50

## Reason for recall

Lack of Assurance of Sterility

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1279-2022
- **Recalling firm:** Nephron Sterile Compounding Center LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-06-30
- **Report date:** 2022-07-27
- **Termination date:** 2024-06-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** West Columbia, SC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1279-2022

## Citation

> AI Analytics. FDA recall D-1279-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1279-2022. Source: US FDA. Licensed CC0.

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