The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-334-2014·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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 corresponds to a moderate severity level involving a reasonable probability of temporary or medically reversible adverse health consequences, without reports of serious injury or death.

Plain-English summary

Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Exforge (amlodipine and valsartan, Tablets) 10/320 mg. The recall involves 951,109 bottles distributed nationwide and in Puerto Rico. The specific product code is 710007 & 725277, with various lot numbers and expiration dates ranging from 11/30/2013 to 01/31/2015.

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

Consumers and healthcare providers should stop using the affected Exforge physician sample bottles and contact their pharmacist or Novartis for further instructions. The agency classified this recall as Class II, indicating a reasonable probability of temporary or medically reversible adverse health consequences.

The recalled product

Product
Exforge (amlodipine and valsartan, Tablets) 10/320 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 # 0078-9491-07
Manufacturer
Novartis Pharmaceuticals Corp.
Category
Drug — Prescription Medication
Hazard
Affected units
951,109

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: 710007 & 725277
  • Lot Number: F0131
  • Exp 11/30/2013
  • F0138
  • Exp 01/31/2014
  • F0137
  • F0139
  • F0140
  • F0141
  • F0142
  • F0142A
  • Exp 02/28/2014
  • F0145
  • F0150
  • F0157
  • F0158
  • Exp 04/30/2014
  • F0159
  • F0160
  • Exp 05/31/2014

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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