The Recall Desk
ModerateFDA (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.

What this means for you

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
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 →

Related recalls

Same manufacturer · Novartis Pharmaceuticals Corp.

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Same hazard · chemical contamination

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