Agency classClass IIOur severity:Moderate FDA (Drugs)·D-338-2014·Announced 2013-12-18

Novartis Recalls Tekturna Tablets Due to Chemical Contamination

Novartis is recalling Tekturna physician sample bottles contaminated with Darocur 1173, a photocuring agent found in ink.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Tekturna (aliskiren) Tablets 300 mg. The recall also includes other Novartis products such as Diovan, Exforge, Exforge HCT, Lescol XL, Stalevo, and Tekturna HCT Tablets. The affected Tekturna bottles contain 7 tablets each and are labeled as 'Physician Sample-Not For Sale, Rx only.'

The recall was initiated due to chemical contamination with Darocur 1173, a photocuring agent used in inks on shrink-wrap sleeves. The source text does not specify the exact mechanism of transfer or the concentration of the contaminant.

The recall covers 128,964 bottles distributed nationwide and in Puerto Rico. Affected lot numbers include F0140, F0140W1, F0142, F0143, F0144, and F0145, with expiration dates ranging from September 2013 to January 2015. Consumers and healthcare providers should check their inventory for these specific lot numbers and contact Novartis for further instructions.

The recalled product

Product: Tekturna (aliskiren) Tablets 300 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Produktions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9486-07
Manufacturer: Novartis Pharmaceuticals Corp.
Category: Drug — Prescription Medication
Hazard: chemical-contamination
Affected units: 128,964

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

Product code: 708239
Lot Number: F0140
F0140W1
Exp 09/30/2013
F0142
Exp 07/31/2014
F0143
Exp 08/31/2014
F0144
Exp 10/31/2014
F0145
Exp 01/31/2015.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 15 recalled by Novartis Pharmaceuticals Corp. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 15 products in this recall →

Same manufacturer · Novartis Pharmaceuticals Corp.

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Same hazard · chemical contamination