# FDA recall D-1078-2019

> **KRS Global Biotechnology, Inc** · Class II · drug recall initiated 2019-01-16.

## Product

NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 mL IV bag,  Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321678343

## Reason for recall

Labeling: Label mix-up

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1078-2019
- **Recalling firm:** KRS Global Biotechnology, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-01-16
- **Report date:** 2019-04-10
- **Termination date:** 2021-02-04

- **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-1078-2019

## Citation

> AI Analytics. FDA recall D-1078-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-1078-2019. Source: US FDA. Licensed CC0.

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