Teva Recalls Capecitabine Tablets Due to Failed Dissolution Specifications
Teva North America is recalling 1,895 bottles of Capecitabine tablets because they failed dissolution specifications at the 18-month time point.
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 2/5 (Moderate).
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, and the hazard involves a failure in dissolution specifications which may affect drug efficacy but does not involve immediate physical injury or contamination.
Plain-English summary
Teva North America is voluntarily recalling 1,895 bottles of Capecitabine tablets USP 500 mg. The recall was initiated because the product failed dissolution specifications, specifically showing low test results at the 18-month time point.
The affected product is identified by Lot # 3A404012V and has an expiration date of 4/2016. The tablets are packaged in bottles of 120 and are distributed nationwide. The product is a prescription-only cytotoxic agent manufactured in the Czech Republic by Teva Czech Industries sro for Teva Pharmaceuticals USA.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or physician for guidance on obtaining a replacement. Patients should not discontinue their cancer treatment without consulting their healthcare provider.
The recalled product
- Product
- CAPECITABINE (CAPECITABINE)
- Brand
- CAPECITABINE
- Manufacturer
- Teva North America
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,895
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 (2)
- Lot # 3A404012V
- Exp. 4/2016
Distribution
Distributed nationwide across the United States.
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