# FDA recall D-1575-2020

> **Mylan Institutional LLC** · Class I · drug recall initiated 2020-08-17.

## Product

Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vial (NDC 67457-153-99); 10 x 9 mL Single-Dose Vials per carton (NDC 67457-153-09), Rx only, Manufactured by: Mylan Institutional, Galway, Ireland; Manufactured for: Mylan Institutional LLC, Rockford, IL  61103.

## Reason for recall

Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1575-2020
- **Recalling firm:** Mylan Institutional LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-08-17
- **Report date:** 2020-09-09
- **Termination date:** 2022-12-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rockford, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1575-2020

## Citation

> AI Analytics. FDA recall D-1575-2020. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1575-2020. Source: US FDA. Licensed CC0.

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