Capecitabine Tablet, Film Coated
FDA Recall NDC 0093-7474
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Capecitabine (NDC 0093-7474). A significant event, classified as Class II, was initiated on Dec 21, 2015 by Teva Pharmaceuticals Usa, Inc.. The reported reason for this action was: "Failed Dissolution Specifications: low test results at the 18 month time-point"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed Dissolution Specifications: low test results at the 18 month time-point
Dec 21, 2015
Mar 09, 2016
1,895 bottles
Recall Profile & Regulatory Data
Event ID
72912
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva North America
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jan 13, 2017
Product Description
Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Teva Czech Industries sro, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7474-89
Batch or Lot Expiration Information
Lot# 3A404012V, Exp. 4/2016
Affected Packages Involved in this Recall
0093-7473-06Product
0093-7474-89Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
