# FDA recall D-0366-2025

> **The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories** · Class II · drug recall initiated 2025-04-14.

## Product

ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61

## Reason for recall

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-0366-2025
- **Recalling firm:** The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-04-14
- **Report date:** 2025-04-23

- **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-0366-2025

## Citation

> AI Analytics. FDA recall D-0366-2025. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0366-2025. Source: US FDA. Licensed CC0.

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