The Recall Desk
ModerateFDA (Drugs)·D-328-2014·Announced 2013-12-18

Novartis Recalls Exforge Physician Samples Due to Chemical Contamination

Novartis is recalling Exforge physician sample bottles due to contamination 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, which typically involves a situation that may cause temporary or medically reversible adverse health consequences. The source does not report any illnesses or injuries, and the hazard is a chemical contamination from packaging ink rather than a high-risk pathogen or structural defect.

Plain-English summary

Novartis Pharmaceuticals Corporation has initiated a recall of physician sample bottles of Exforge (amlodipine and valsartan Tablets) 5/160 mg. The recall also includes physician samples of Diovan, Exforge HCT, Lescol XL, Stalevo, Tekturna, and Tekturna HCT Tablets.

The recall was issued because the products were contaminated with Darocur 1173, a photocuring agent used in inks on shrink-wrap sleeves. The affected products are identified by NDC # 0078-9488-07 and specific lot numbers and expiration dates listed in the recall notice.

The recall covers 1,492,475 bottles distributed nationwide and in Puerto Rico. Consumers and healthcare providers should stop using these specific physician sample bottles and contact their pharmacist or Novartis for further instructions.

The recalled product

Product
Exforge (amlodipine and valsartan Tablets) 5/160 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 # 0078-9488-07
Manufacturer
Novartis Pharmaceuticals Corp.
Category
Drug — Prescription Medication
Hazard
Affected units
1,492,475

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 (20)

  • Product code: 709999 & 725275
  • Lot Number: F0048A
  • Exp 08/31/2013
  • F0056A
  • Exp 10/31/2013
  • F0084
  • F0085
  • Exp 01/31/2014
  • F0059A
  • F0088
  • Exp 02/28/2014
  • F0086
  • F0087
  • Exp 03/31/2014
  • F0061A
  • F0063W1
  • Exp 05/31/2014
  • F0070A
  • Exp 09/30/2014
  • F0082A

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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