# FDA recall D-1146-2018

> **RemedyRepack Inc.** · Class II · drug recall initiated 2018-08-20.

## Product

Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma LTD, Indrad, India 38272, NDC #70518-1220-0

## Reason for recall

CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.

## Distribution

South Carolina

## Key facts

- **Recall number:** D-1146-2018
- **Recalling firm:** RemedyRepack Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-08-20
- **Report date:** 2018-09-05
- **Termination date:** 2018-10-10

- **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-1146-2018

## Citation

> AI Analytics. FDA recall D-1146-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-1146-2018. Source: US FDA. Licensed CC0.

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