The Recall Desk
HighFDA (Drugs)·D-340-2014·Announced 2013-12-18

Novartis Recalls Tekturna HCT Physician Samples Due to Chemical Contamination

Novartis is recalling Tekturna HCT physician sample bottles due to contamination with Darocur 1173, a photo curing agent used in ink.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves chemical contamination with a photo curing agent, which poses a risk of harm even though no specific injuries are reported in the source text.

Plain-English summary

Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 300/25 mg. The recall affects 70,006 bottles distributed nationwide and in Puerto Rico. The specific product code is 712427, with lot numbers F0036, F0036W1, F0038, and F0039.

The recall was initiated due to chemical contamination with Darocur 1173, a photo curing agent used in inks on shrink-wrap sleeves. This contamination also affected other Novartis products, including Diovan, Exforge, Exforge HCT, Lescol XL, Stalevo, and Tekturna.

Consumers and healthcare providers should stop using the affected physician sample bottles and contact their pharmacist or Novartis for further instructions. The affected bottles are labeled 'Physician Sample-Not For Sale' and 'Rx only'.

The recalled product

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
Manufacturer
Novartis Pharmaceuticals Corp.
Category
Drug — Prescription Medication
Hazard
Affected units
70,006

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 (8)

  • Product code: 712427
  • Lot Number: F0036
  • F0036W1
  • Exp 08/31/2013
  • F0038
  • Exp 06/30/2014
  • F0039
  • Exp 08/31/2014.

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 →

Related recalls

Same manufacturer · Novartis Pharmaceuticals Corp.

See all →

Same hazard · chemical contamination

See all →