D-326-2014 Class II Terminated
FDA drug recall D-326-2014 was initiated by Novartis Pharmaceuticals Corp. on Aug 8, 2013 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Dec 21, 2015). Affected quantity: 139,788 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Dec 18, 2013
- Initiation Date
- Aug 8, 2013
- Termination Date
- Dec 21, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 139,788 bottles
Product description
Diovan (valsartan) 160 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale, Manufactured by: Novartis Pharmaceuticals Corporation Suffern, NY 10901 for Novartis Pharmaceuticals Corporation East Hanover, NJ 07936, NDC # 0078-9359-07
Reason for recall
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.
Distribution pattern
Nationwide and Puerto Rico
Code information
Product code: 704412; Lot Number: F1186, Exp 03/31/2014; F1127, F1127A, Exp 07/31/2014
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-326-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026