Agency classClass IIOur severity:Moderate FDA (Drugs)·D-333-2014·Announced 2013-12-18

Novartis Recalls Physician Sample Blood Pressure Medications Due to Chemical Contamination

Novartis is recalling physician sample bottles of several blood pressure medications due to contamination with a photocuring agent found in packaging 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 the product may cause temporary or medically reversible adverse health consequences. The hazard is chemical contamination from packaging inks, which is a low-risk contamination scenario.

Plain-English summary

Novartis Pharmaceuticals Corporation is recalling 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 products are prescription-only physician samples that are not for sale. The recall covers 61,124 bottles distributed nationwide and in Puerto Rico. Specific lot numbers and expiration dates are listed in the product code information.

Consumers and healthcare providers should stop using the affected products and contact Novartis Pharmaceuticals Corporation for further instructions on how to return or dispose of the medication.

The recalled product

Product: Exforge (amlodipine and valsartan Tablets) 10/160 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 # 0078-9489-07
Manufacturer: Novartis Pharmaceuticals Corp.
Category: Drug — Prescription Medication
Hazard: chemical-contamination
Affected units: 611,240

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 (13)

Product code: 710011
Lot Number: F0060
Exp 01/31/2014
F0028A
Exp 02/28/2014
F0061
Exp 03/31/2014
F0062
Exp 05/31/2014
F0033A
Exp 10/31/2014
F0037A
Exp 01/31/2015

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 15 products in this recall →

Same manufacturer · Novartis Pharmaceuticals Corp.

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Same hazard · chemical contamination