Status
Terminated
Drug Enforcement D-332-2014
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.
Classification
Class II
Report Date
December 18, 2013
Termination Date
December 21, 2015
Product Information
- Product description
- 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
- Product quantity
- 174,848 bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Novartis Pharmaceuticals Corp.
- Address
-
25 Old Mill Rd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-332-2014
- Event ID
- 66015
- Recall initiation date
- August 8, 2013
- Center classification date
- December 6, 2013
- Code info
- Product code: 715515; Lot Number: F0012, Exp 10/31/2013; F0013, Exp 02/28/2014; F0014, Exp 03/31/2014
- More code info
- —