Schering-Plough Products, LLC recalls Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration, Rx Only, Cytotoxic,
Recalled February 6, 2013 · FDA recall D-139-2013 · Schering-Plough Products
Hazard
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. · FDA Class II
Units
17,169 Packages
Sold at
Nationwide and Puerto Rico
Description
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.
Product
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
Manufacturer(s)
Schering-Plough Products, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →