# FDA recall D-0324-2024

> **The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories** · Class II · drug recall initiated 2024-02-09.

## Product

HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia MI. NDC 0904-6440-61

## Reason for recall

an out of specification result obtained during routine stability testing for Impurities.  There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.

## Distribution

The product was distributed nationwide within the United States.

## Key facts

- **Recall number:** D-0324-2024
- **Recalling firm:** The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-02-09
- **Report date:** 2024-02-21
- **Termination date:** 2025-12-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** La Vergne, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0324-2024

## Citation

> AI Analytics. FDA recall D-0324-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0324-2024. Source: US FDA. Licensed CC0.

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