Novartis Recalls Tekturna HCT Physician Samples Due to Chemical Contamination
Novartis is recalling Tekturna HCT physician sample bottles due to contamination with Darocur 1173, a photo curing agent used in ink.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves chemical contamination with a photo curing agent, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 300/25 mg. The recall affects 70,006 bottles distributed nationwide and in Puerto Rico. The specific product code is 712427, with lot numbers F0036, F0036W1, F0038, and F0039.
The recall was initiated due to chemical contamination with Darocur 1173, a photo curing agent used in inks on shrink-wrap sleeves. This contamination also affected other Novartis products, including Diovan, Exforge, Exforge HCT, Lescol XL, Stalevo, and Tekturna.
Consumers and healthcare providers should stop using the affected physician sample bottles and contact their pharmacist or Novartis for further instructions. The affected bottles are labeled 'Physician Sample-Not For Sale' and 'Rx only'.
The recalled product
- Product
- Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 300/25 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…
- Manufacturer
- Novartis Pharmaceuticals Corp.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 70,006
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Product code: 712427
- Lot Number: F0036
- F0036W1
- Exp 08/31/2013
- F0038
- Exp 06/30/2014
- F0039
- Exp 08/31/2014.
Distribution
Part of a larger recall action
This product is one of 15 recalled by Novartis Pharmaceuticals Corp. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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