Class II
Terminated
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
This recall has been terminated (originally issued February 6, 2013).
- Company
- Schering-Plough Products, Llc
- Recall Initiated
- December 12, 2012
- Posted
- February 6, 2013
- Recall Number
- D-139-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 17,169 Packages
- Firm Location
- Las Piedras, PR, United States
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot: 0NCW005, Exp 02/2013
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