The Recall Desk
ModerateFDA (Drugs)·D-333-2014·Announced 2013-12-18

Novartis Recalls Physician Sample Blood Pressure Medications Due to Chemical Contamination

Novartis is recalling physician sample bottles of several blood pressure medications due to contamination with a photocuring agent found in packaging inks.

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 indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is chemical contamination from packaging inks, which is a low-risk contamination scenario.

Plain-English summary

Novartis Pharmaceuticals Corporation is recalling physician sample bottles of Diovan, Exforge, Exforge HCT, Lescol XL, Stalevo, Tekturna, and Tekturna HCT tablets. The recall is due to contamination with Darocur 1173, a photocuring agent used in inks on shrink-wrap sleeves.

The affected products are prescription-only physician samples that are not for sale. The recall covers 61,124 bottles distributed nationwide and in Puerto Rico. Specific lot numbers and expiration dates are listed in the product code information.

Consumers and healthcare providers should stop using the affected products and contact Novartis Pharmaceuticals Corporation for further instructions on how to return or dispose of the medication.

The recalled product

Product
Exforge (amlodipine and valsartan Tablets) 10/160 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9489-07
Manufacturer
Novartis Pharmaceuticals Corp.
Category
Drug — Prescription Medication
Hazard
Affected units
611,240

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 (13)

  • Product code: 710011
  • Lot Number: F0060
  • Exp 01/31/2014
  • F0028A
  • Exp 02/28/2014
  • F0061
  • Exp 03/31/2014
  • F0062
  • Exp 05/31/2014
  • F0033A
  • Exp 10/31/2014
  • F0037A
  • 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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