# FDA recall D-340-2014

> **Novartis Pharmaceuticals Corp.** · Class II · drug recall initiated 2013-08-08.

## Product

Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 300/25 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only,  Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany.  Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9524-89

## Reason for recall

Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photo curing agent used in inks on shrink-wrap sleeves.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-340-2014
- **Recalling firm:** Novartis Pharmaceuticals Corp.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-08-08
- **Report date:** 2013-12-18
- **Termination date:** 2015-12-21

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-340-2014

## Citation

> AI Analytics. FDA recall D-340-2014. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-340-2014. Source: US FDA. Licensed CC0.

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