Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administratio...
FDA Recall #D-139-2013 — Class II — December 12, 2012
Product Description
Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration, Rx Only, Cytotoxic, NDC: 0085-1519-02, Schering Corporation, Kenilworth, New Jersey, 07033
Reason for Recall
Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability monitoring.
Recalling Firm
Schering-Plough Products, LLC — Las Piedras, PR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
17,169 Packages
Distribution
Nationwide and Puerto Rico
Code Information
Lot: 0NCW005, Exp 02/2013
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated