# FDA recall D-0122-2020

> **Torrent Pharma Inc.** · Class II · drug recall initiated 2019-09-19.

## Product

Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for:  Torrent Pharma Inc., Basking Ridge, NJ 07920.  NDC 90 tablets: 13668-115-90; NDC 1000 tablets: 13668-115-10

## Reason for recall

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.

## Distribution

Nationwide USA and Puerto Rico

## Key facts

- **Recall number:** D-0122-2020
- **Recalling firm:** Torrent Pharma Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2019-09-19
- **Report date:** 2019-10-09

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0122-2020

## Citation

> AI Analytics. FDA recall D-0122-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0122-2020. Source: US FDA. Licensed CC0.

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