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.
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 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 #…
- 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
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.
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