# FDA recall D-0640-2021

> **VIONA PHARMACEUTICALS INC** · Class II · drug recall initiated 2021-06-01.

## Product

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016  NDC 72578-036-01

## Reason for recall

CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-0640-2021
- **Recalling firm:** VIONA PHARMACEUTICALS INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-06-01
- **Report date:** 2021-06-30
- **Termination date:** 2023-05-31

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0640-2021

## Citation

> AI Analytics. FDA recall D-0640-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0640-2021. Source: US FDA. Licensed CC0.

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