FDA-Drug2013-02-06Class II
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
Schering-Plough Products, LLC
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.
Sold states
Nationwide and Puerto Rico
Affected count
17,169 Packages
Manufactured in
Pridco Industrial Park, Road # 183, Las Piedras, PR, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-139-2013Don't want to check this manually?
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