The Recall Desk
SevereFDA (Drugs)·D-335-2014·Announced 2013-12-18

Novartis Recalls Lescol XL Tablets Due to Chemical Contamination

Novartis is recalling Lescol XL tablets contaminated with Darocur 1173, a photocuring agent found in ink on shrink-wrap sleeves.

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 rating under the rubric for significant injury or property damage reports, or high-risk contamination.

Plain-English summary

Novartis Pharmaceuticals Corporation has recalled specific bottles of Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80 mg. The recall involves 46,812 bottles of the product, which is distributed nationwide and in Puerto Rico. The affected product is identified by Product Code 707136, Lot Number F0017, and an expiration date of 01/31/2015.

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

Consumers and healthcare providers should check their inventory for the specific lot and product code listed above. If the product matches the recalled description, it should be discontinued and returned to the pharmacy or supplier for replacement or refund.

The recalled product

Product
Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80 mg per tablet, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936,
Manufacturer
Novartis Pharmaceuticals Corp.
Category
Drug — Prescription Medication
Hazard
Affected units
46,812

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: 707136
  • Lot Number: F0017
  • 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 →

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