The Recall Desk
ModerateFDA (Drugs)·D-339-2014·Announced 2013-12-18

Novartis Recalls Tekturna HCT Physician Samples Due to Chemical Contamination

Novartis is recalling physician sample bottles of Tekturna HCT and other medications due to contamination with Darocur 1173, a photo-curing agent.

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, which typically involves a situation that may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is a chemical contamination from packaging inks, fitting the criteria for a moderate severity score.

Plain-English summary

Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 150/12.5 mg. The recall also includes physician sample bottles of Diovan, Exforge, Exforge HCT, Lescol XL, and Stalevo. The affected Tekturna HCT bottles are identified by NDC # 0078-9521-89, Product Code 712396, and Lot Numbers F0026 and F0027, with an expiration date of 07/31/2014.

The recall was initiated due to chemical contamination with Darocur 1173, a photo-curing agent used in inks on shrink-wrap sleeves. The source text does not specify the exact quantity of Tekturna HCT bottles recalled, though the structured metadata indicates 16,693 bottles for this specific product code. The distribution pattern for the affected products is nationwide and Puerto Rico.

Consumers and healthcare providers should check their inventory for these specific lot numbers and product codes. If found, the products should be removed from use and returned to the distributor or recalled firm as directed by Novartis Pharmaceuticals Corporation.

The recalled product

Product
Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 150/12.5 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 , ND
Manufacturer
Novartis Pharmaceuticals Corp.
Category
Drug — Prescription Medication
Hazard
Affected units
16,693

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 (4)

  • Product code: 712396
  • Lot Number: F0026
  • F0027
  • Exp 07/31/2014

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 →

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