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
Tekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9485-07
Lot numbers, UPCs & expiration codes
Product code: 708236; Lot Number: F0116, F0116W1, F0016W2, Exp 09/30/2013; F0117, Exp 02/28/2014; F0118, 6) F0119, Exp 08/31/2014
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-337-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 8, 2013
- FDA report date
- Dec 18, 2013
- Quantity
- 12,6245 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novartis Pharmaceuticals Corp.
Original FDA data
Every field from FDA enforcement report D-337-2014, 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: 708236; Lot Number: F0116, F0116W1, F0016W2, Exp 09/30/2013; F0117, Exp 02/28/2014; F0118, 6) F0119, Exp 08/31/2014
- Postal code
- 10901-4106
- Report date
- Dec 18, 2013
- Product type
- Drugs
- Recall number
- D-337-2014
- Classification
- Class II
- Recalling firm
- Novartis Pharmaceuticals Corp.
- Product quantity
- 12,6245 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
- Tekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9485-07
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Aug 8, 2013
- Initial firm notification
- Letter
- Center classification date
- Dec 6, 2013