FDAFDA · Food and drugs·Recall number D-139-2013
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
Published February 6, 2013 · Recall initiated: December 12, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Schering-Plough Products, LLC
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot: 0NCW005, Exp 02/2013
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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