# FDA recall D-0320-2024

> **Amerisource Health Services LLC** · Class III · drug recall initiated 2024-02-01.

## Product

HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.  NDC Carton: 68084-447-01;  NDC Unit Dose: 68084-447-11

## Reason for recall

Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0320-2024
- **Recalling firm:** Amerisource Health Services LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-02-01
- **Report date:** 2024-02-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Columbus, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0320-2024

## Citation

> AI Analytics. FDA recall D-0320-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0320-2024. Source: US FDA. Licensed CC0.

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