The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-326-2014·Announced 2013-12-18

Novartis Recalls Diovan and Other Tablets Due to Chemical Contamination

Novartis is recalling physician sample bottles of several prescription tablets, including Diovan, due to contamination with a photocuring agent.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving chemical contamination that may pose a risk of harm.

Plain-English summary

Novartis Pharmaceuticals Corporation has initiated a recall of physician sample bottles for several prescription medications, including Diovan, Exforge, Exforge HCT, Lescol XL, Stalevo, Tekturna, and Tekturna HCT. The recall involves 139,788 bottles of Diovan (valsartan) 160 mg, specifically the 7-tablet physician sample bottles. The affected products were distributed nationwide and in Puerto Rico.

The recall was issued due to chemical contamination with Darocur 1173, a photocuring agent used in inks on shrink-wrap sleeves. The agency has classified this recall as Class II. Specific lot numbers for the Diovan product include F1186 (expiring 03/31/2014) and F1127/F1127A (expiring 07/31/2014).

Consumers and healthcare providers should stop using the affected products and contact their healthcare provider or pharmacist for guidance. The recall is limited to physician sample bottles marked 'Rx only Physician Sample Not For Sale.'

The recalled product

Product
Diovan (valsartan) 160 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 # 0078-9359-07
Manufacturer
Novartis Pharmaceuticals Corp.
Category
Drug — Prescription Medication
Hazard
Affected units
139,788

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 (6)

  • Product code: 704412
  • Lot Number: F1186
  • Exp 03/31/2014
  • F1127
  • F1127A
  • Exp 07/31/2014

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 →

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