The Recall Desk
ModerateFDA (Drugs)·D-337-2014·Announced 2013-12-18

Novartis Recalls Physician Sample Tablets Due to Chemical Contamination

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

What this means for you

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 temporary or medically reversible adverse health consequence. The hazard is chemical contamination from packaging inks, which is a lower risk compared to biological pathogens or structural defects.

Plain-English summary

Novartis Pharmaceuticals Corporation has initiated a recall of physician sample bottles for several prescription medications, including Tekturna (aliskiren) Tablets 150 mg. The recall also affects Diovan, Exforge, Exforge HCT, Lescol XL, Stalevo, and Tekturna HCT Tablets. The specific product identified in the metadata is Tekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, marked as Physician Sample-Not For Sale.

The recall is due to chemical contamination with Darocur 1173, a photocuring agent used in inks on shrink-wrap sleeves. The affected units were distributed nationwide and in Puerto Rico. The recall involves specific lot numbers and expiration dates, including F0116, F0116W1, F0016W2, F0117, F0118, and F0119.

Consumers and healthcare providers should check their inventory for these specific physician sample bottles. If the product matches the recalled description and lot numbers, it should be returned to the pharmacy or supplier for disposal or replacement according to Novartis instructions.

The recalled product

Product
Tekturna (aliskiren) Tablets 150 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 # 0078-9485-07
Manufacturer
Novartis Pharmaceuticals Corp.
Category
Drug — Prescription Medication
Hazard
Affected units
126,245

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 (10)

  • Product code: 708236
  • Lot Number: F0116
  • F0116W1
  • F0016W2
  • Exp 09/30/2013
  • F0117
  • Exp 02/28/2014
  • F0118
  • 6) F0119
  • Exp 08/31/2014

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 →

Related recalls

Same manufacturer · Novartis Pharmaceuticals Corp.

See all →

Same hazard · chemical contamination

See all →