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.
Product description
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, NDC # 0078-9559-89
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-331-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 8, 2013
- FDA report date
- Dec 18, 2013
- Quantity
- 328,543 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novartis Pharmaceuticals Corp.
Original FDA data
Every field from FDA enforcement report D-331-2014, exactly as published.
Show all FDA fields
- City
- Suffern
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 66015
- Address
- 25 Old Mill Rd
- Code information
- 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
- Postal code
- 10901-4106
- Report date
- Dec 18, 2013
- Product type
- Drugs
- Recall number
- D-331-2014
- Classification
- Class II
- Recalling firm
- Novartis Pharmaceuticals Corp.
- Product quantity
- 328,543 bottles
- Termination date
- Dec 21, 2015
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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, NDC # 0078-9559-89
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Aug 8, 2013
- Initial firm notification
- Letter
- Center classification date
- Dec 6, 2013