The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-329-2014·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 used 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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures.

Plain-English summary

Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Exforge (amlodipine and valsartan Tablets) 5/320 mg. The recall involves 869,951 bottles distributed nationwide and in Puerto Rico.

The recall was initiated due to contamination with Darocur 1173, a photocuring agent used in inks on shrink-wrap sleeves. This chemical contamination affects specific lots of the product, including lot numbers F0102, F0115, F0116, F0105, F0109, F0111, F0112, F0121, F0122, F0125A, F0125W1, F0137, F0139, F0140, F0141, F0142, and F0144.

Physician samples are intended for medical professionals and are not for sale. Patients and healthcare providers should check their inventory for the affected lot numbers and expiration dates listed in the recall notice. If the product is found, it should be returned to the distributor or disposed of according to local regulations.

The recalled product

Product
Exforge (amlodipine and valsartan Tablets) 5/320 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 # 0078-9490-07
Manufacturer
Novartis Pharmaceuticals Corp.
Category
Drug — Prescription Medication
Hazard
Affected units
869,951

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: 710003
  • Lot Number: F0102
  • Exp 11/30/2013
  • F0115
  • F0116
  • Exp 01/31/2014
  • F0105
  • F0109
  • F0111
  • F0112
  • Exp 02/28/2014
  • F0121
  • F0122
  • Exp 05/31/2014
  • F0125A
  • F0125W1
  • Exp 07/31/2014
  • F0137
  • F0139
  • F0140

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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