# FDA recall D-0584-2024

> **The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories** · Class II · drug recall initiated 2024-06-18.

## Product

Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Major Pharmaceutical 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, USA, NDC 0904-7075-61, UPC code: 309047075614

## Reason for recall

Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.

## Distribution

Nationwide. No foreign consignees.

## Key facts

- **Recall number:** D-0584-2024
- **Recalling firm:** The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-06-18
- **Report date:** 2024-07-10
- **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-0584-2024

## Citation

> AI Analytics. FDA recall D-0584-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0584-2024. Source: US FDA. Licensed CC0.

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