Novartis Recalls Diovan and Other Tablets Due to Chemical Contamination
Novartis is recalling physician sample bottles of Diovan and other tablets because they were contaminated with Darocur 1173, a photocuring agent used in inks.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible health consequences. The source text does not report any illnesses or injuries, and the contamination is identified as a chemical agent from packaging inks rather than a high-risk pathogen or structural defect.
Plain-English summary
Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT, Lescol XL, Stalevo, Tekturna, and Tekturna HCT tablets. The recall is due to contamination with Darocur 1173, a photocuring agent used in inks on shrink-wrap sleeves.
The affected product includes Diovan (valsartan) 320 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale. The specific product code is 704414, Lot Number F1027, with an expiration date of 2/28/2014. The total quantity involved is 57,881 bottles.
The products were distributed nationwide and in Puerto Rico. Consumers and healthcare providers should stop using the affected products and contact their healthcare provider or pharmacist for guidance on next steps.
The recalled product
- Product
- Diovan (valsartan) 320 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 # 0078-9360-07
- Manufacturer
- Novartis Pharmaceuticals Corp.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 57,881
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 (3)
- Product code: 704414
- Lot Number: F1027
- Exp 2/28/2014
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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