# FDA recall D-0039-2024

> **Amerisource Health Services LLC** · Class III · drug recall initiated 2023-09-01.

## Product

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

## Reason for recall

Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0039-2024
- **Recalling firm:** Amerisource Health Services LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-09-01
- **Report date:** 2023-10-11
- **Termination date:** 2024-07-16

- **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-0039-2024

## Citation

> AI Analytics. FDA recall D-0039-2024. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/D-0039-2024. Source: US FDA. Licensed CC0.

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