Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured i...
FDA Recall #D-0732-2016 — Class II — December 21, 2015
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
Reason for Recall
Failed Dissolution Specifications: low test results at the 18 month time-point
Recalling Firm
Teva North America — Horsham, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1,895 bottles
Distribution
Nationwide
Code Information
Lot # 3A404012V, Exp. 4/2016
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated