Temodar recall: Impurity Out of Spec
Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration, Rx Only, Cytotoxic, NDC: 0085-1519-02, Schering…
Why was Temodar recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: 0NCW005, Exp 02/2013
- Product
- Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration, Rx Only, Cytotoxic, NDC: 0085-1519-02, Schering…
- Recalling firm
- Schering-Plough Products, LLC
- Quantity
- 17,169 Packages
- Distribution
- Nationwide and Puerto Rico
- Recall date
- February 6, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)