# FDA recall D-0653-2022

> **The Harvard Drug Group** · Class II · drug recall initiated 2022-02-24.

## Product

hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61

## Reason for recall

Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.

## Distribution

Nationwide within USA

## Key facts

- **Recall number:** D-0653-2022
- **Recalling firm:** The Harvard Drug Group
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-02-24
- **Report date:** 2022-03-23
- **Termination date:** 2023-07-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Livonia, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0653-2022

## Citation

> AI Analytics. FDA recall D-0653-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0653-2022. Source: US FDA. Licensed CC0.

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