December 2015 FDA Recall Capecitabine by Teva North America
D-0732-2016 - Failed Dissolution Specifications

This Class II drug recall was voluntarily initiated by Teva North America on December 21, 2015 for the product Capecitabine. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0732-2016

Reason for Recall
Failed Dissolution Specifications: low test results at the 18 month time-point
Initiated
12-21-2015
Reported
03-09-2016
Quantity
1,895 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72912
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teva North America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
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

0093-7473-06 Capecitabine
0093-7474-89 Capecitabine