US Drug Recall Register
Class II · Moderate risk Terminated Initiated Aug 8, 2013 (13 years ago)

Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only, 7 tablets…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.

What was recalled

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 # 0078-9560-89

Recalling firm
Novartis Pharmaceuticals Corp.
NDC code
0078-9560-89
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-332-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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