# FDA recall D-0389-2024

> **Novitium Pharma LLC** · Class III · drug recall initiated 2024-03-04.

## Product

Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-201-20

## Reason for recall

Cross Contamination with Other Products:(mycophenolate mofetil).

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0389-2024
- **Recalling firm:** Novitium Pharma LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-03-04
- **Report date:** 2024-03-27
- **Termination date:** 2025-03-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Windsor, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0389-2024

## Citation

> AI Analytics. FDA recall D-0389-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0389-2024. Source: US FDA. Licensed CC0.

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