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Recall Observatory FDA recall evidence

Drug 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

D-139-2013

December 12, 2012

Class II

Product summary

Firm
Schering-Plough Products, LLC
Event
Event 63879
Status
Terminated
Classification
Class II
Quantity
17,169 Packages
Official record key
drug-enforcement:D-139-2013

Official wording

Reason: 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.

Code information: Lot: 0NCW005, Exp 02/2013

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out-of-specification