# FDA recall D-1551-2022

> **AuroMedics Pharma LLC** · Class III · drug recall initiated 2022-09-26.

## Product

Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Windsor, NJ 08520, Made in India, NDC 55150-188-10

## Reason for recall

Presence of Particulate Matter: Piece of metal found in a vial

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-1551-2022
- **Recalling firm:** AuroMedics Pharma LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2022-09-26
- **Report date:** 2022-10-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Windsor, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1551-2022

## Citation

> AI Analytics. FDA recall D-1551-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1551-2022. Source: US FDA. Licensed CC0.

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