Drug recall D-139-2013
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
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.
Lots and codes
Lot: 0NCW005, Exp 02/2013
Recall details
- Recalling firm
- Schering-Plough Products, LLC, Las Piedras, PR
- Quantity
- 17,169 Packages
- Distribution
- Nationwide and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 12, 2012
- Terminated
- January 3, 2014
Related products
- NDC 0085-1519 Temodar · Temozolomide 20 mg/1 · Merck Sharp & Dohme LLC