# FDA recall D-1144-2018

> **Torrent Pharma Inc.** · Class II · drug recall initiated 2018-08-17.

## Product

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by:  Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-328-30

## Reason for recall

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-1144-2018
- **Recalling firm:** Torrent Pharma Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2018-08-17
- **Report date:** 2018-09-05

- **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-1144-2018

## Citation

> AI Analytics. FDA recall D-1144-2018. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/D-1144-2018. Source: US FDA. Licensed CC0.

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