# FDA recall D-1270-2019

> **RemedyRepack Inc.** · Class II · drug recall initiated 2019-04-22.

## Product

Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured by Torrent Pharmaceuticals, Distributed by RemedyRepack, Inc. Indiana, PA, 15701-3570, NDC 70518-1560-00.

## 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 0.96 parts per million.

## Distribution

Product was distributed to Florida.

## Key facts

- **Recall number:** D-1270-2019
- **Recalling firm:** RemedyRepack Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-04-22
- **Report date:** 2019-05-08
- **Termination date:** 2020-05-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indiana, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1270-2019

## Citation

> AI Analytics. FDA recall D-1270-2019. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/D-1270-2019. Source: US FDA. Licensed CC0.

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