# FDA recall D-0056-2021

> **Denton Pharma, Inc.** · Class II · drug recall initiated 2020-10-08.

## Product

Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131  NDC 70934-334-30

## Reason for recall

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

## Distribution

Indiana - Nationwide.

## Key facts

- **Recall number:** D-0056-2021
- **Recalling firm:** Denton Pharma, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2020-10-08
- **Report date:** 2020-11-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Blenheim, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0056-2021

## Citation

> AI Analytics. FDA recall D-0056-2021. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/D-0056-2021. Source: US FDA. Licensed CC0.

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