The Recall Desk
SevereFDA (Drugs)·D-332-2014·Announced 2013-12-18

Novartis Recalls Exforge HCT Physician Samples Due to Chemical Contamination

Novartis is recalling Exforge HCT physician sample bottles contaminated with Darocur 1173, a photocuring agent found in ink on shrink-wrap sleeves.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' severity score under the rubric, as it involves a chemical contamination that could cause serious, reversible health consequences.

Plain-English summary

Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg. The recall affects 174,848 bottles distributed nationwide and in Puerto Rico. The specific product code is 715515, with lot numbers F0012, F0013, and F0014.

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

Consumers and healthcare providers should stop using the affected physician sample bottles and contact Novartis Pharmaceuticals Corporation for further instructions or a replacement. The agency has classified this recall as Class II.

The recalled product

Product
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 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
Manufacturer
Novartis Pharmaceuticals Corp.
Category
Drug — Prescription Medication
Hazard
Affected units
174,848

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 (7)

  • Product code: 715515
  • Lot Number: F0012
  • Exp 10/31/2013
  • F0013
  • Exp 02/28/2014
  • F0014
  • Exp 03/31/2014

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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