The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-331-2014·Announced 2013-12-18

Novartis Recalls Multiple Prescription Medications Due to Chemical Contamination

Novartis is recalling physician sample bottles of several prescription medications due to contamination with 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 involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible health consequences. No specific injuries or illnesses are reported in the source text, and the contamination is from a packaging agent rather than the drug substance itself.

Plain-English summary

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

The affected products are physician samples marked 'Not For Sale' and were distributed nationwide and in Puerto Rico. The recall involves 328,543 bottles across various lot numbers and expiration dates. The agency has classified this as a Class II recall.

Consumers and healthcare providers should stop using the affected products and contact their healthcare provider or pharmacist for guidance on alternative treatments. The specific hazard is chemical contamination from the packaging material.

The recalled product

Product
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12.5 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…
Manufacturer
Novartis Pharmaceuticals Corp.
Category
Drug — Prescription Medication
Hazard
Affected units
328,543

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 (17)

  • Product code: 715523 & 725278
  • Lot Number: F0019
  • F0019A
  • Exp 08/31/2013
  • F0020
  • Exp 09/30/2013
  • F0021
  • F0021A
  • Exp 10/31/2013
  • F0022
  • F0025
  • Exp 11/30/2013
  • F0024
  • F0026
  • Exp 12/31/2013
  • F0027
  • Exp 09/30/2014

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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