# FDA recall D-0153-2024

> **The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories** · Class I · drug recall initiated 2023-10-23.

## Product

Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case (NDC 0904-7079-57), Rx only, Major Pharmaceuticals Livonia, MI 48152

## Reason for recall

Failed Content Uniformity Specifications

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0153-2024
- **Recalling firm:** The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-10-23
- **Report date:** 2023-12-27
- **Termination date:** 2024-07-10

- **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-0153-2024

## Citation

> AI Analytics. FDA recall D-0153-2024. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/D-0153-2024. Source: US FDA. Licensed CC0.

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