# FDA recall D-0013-2023

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

## Product

Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ  08520; Made in India, NDC 55150-154-10.

## Reason for recall

Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0013-2023
- **Recalling firm:** AuroMedics Pharma LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2022-09-26
- **Report date:** 2022-10-26

- **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-0013-2023

## Citation

> AI Analytics. FDA recall D-0013-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0013-2023. Source: US FDA. Licensed CC0.

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