# FDA recall D-0101-2020

> **KRS Global Biotechnology, Inc** · Class II · drug recall initiated 2019-09-12.

## Product

Sodium Bicarbonate 8.4%, 4,200 mg / 50 mL 50 mEq / 50 mL (84 mg/mL) (1 mEq/mL), 50 mL Fill in a 60 mL Single Dose Syringe, For IV Use, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674199

## Reason for recall

Lack of Assurance of Sterility

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0101-2020
- **Recalling firm:** KRS Global Biotechnology, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-09-12
- **Report date:** 2019-10-09
- **Termination date:** 2021-08-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Boca Raton, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0101-2020

## Citation

> AI Analytics. FDA recall D-0101-2020. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0101-2020. Source: US FDA. Licensed CC0.

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