The Recall Desk
SevereFDA (Drugs)·D-336-2014·Announced 2013-12-18

Novartis Recalls Stalevo Tablets Due to Chemical Contamination

Novartis is recalling Stalevo physician sample bottles contaminated with Darocur 1173, a photocuring agent found in ink.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk contamination.

Plain-English summary

Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Stalevo (carbidopa, levodopa, and entacapone) 12.5/50/200 mg. The recall involves 18,665 bottles distributed nationwide and in Puerto Rico. The specific product code is 707156, with Lot Number F0012 and an expiration date of 02/28/2014.

The recall was initiated due to chemical contamination with Darocur 1173, a photocuring agent used in inks on shrink-wrap sleeves. This contamination affected multiple Novartis products, including Diovan, Exforge, Exforge HCT, Lescol XL, Stalevo, Tekturna, and Tekturna HCT tablets.

Consumers and healthcare providers should stop using the affected Stalevo bottles and return them to the pharmacy or contact Novartis for instructions on disposal or replacement.

The recalled product

Product
Stalevo (carbidopa, levodopa, and entacapone) 12.5/50/200 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
Manufacturer
Novartis Pharmaceuticals Corp.
Category
Drug — Prescription Medication
Hazard
Affected units
18,665

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: 707156
  • Lot Number: F0012
  • Exp 02/28/2014

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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