Novartis Recalls Exforge HCT Physician Samples Due to Chemical Contamination
Novartis is recalling Exforge HCT physician sample bottles contaminated with Darocur 1173, a photocuring agent found in ink on shrink-wrap sleeves.
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, as it involves a chemical contamination that could cause serious, reversible health consequences.
Plain-English summary
Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg. The recall affects 174,848 bottles distributed nationwide and in Puerto Rico. The specific product code is 715515, with lot numbers F0012, F0013, and F0014.
The recall was initiated due to contamination with Darocur 1173, a photocuring agent used in inks on shrink-wrap sleeves. This chemical contamination affects multiple Novartis products, including Diovan, Exforge, Lescol XL, Stalevo, Tekturna, and Tekturna HCT.
Consumers and healthcare providers should stop using the affected physician sample bottles and contact Novartis Pharmaceuticals Corporation for further instructions or a replacement. The agency has classified this recall as Class II.
The recalled product
- Product
- Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC…
- Manufacturer
- Novartis Pharmaceuticals Corp.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 174,848
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 (7)
- Product code: 715515
- Lot Number: F0012
- Exp 10/31/2013
- F0013
- Exp 02/28/2014
- F0014
- Exp 03/31/2014
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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