Reported Feb 6, 2013 · Terminated

Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration, Rx Only, Cytotoxic,…

Schering-Plough Products, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Schering-Plough Products, LLC · Pridco Industrial Park · Las Piedras, PR · 00771

Is this the product you have?

  • Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration, Rx Only, Cytotoxic
  • NDC0085-1519-02, Schering Corporation, Kenilworth, New Jersey, 07033
Lot codes and dates
  • Lot
    • 0NCW005
    • Exp 02/2013
Amount recalled
17,169 Packages

Where it was sold

  • Nationwide
  • PR

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jan 3, 2014 · Data as of Sep 19, 7:58 PM UTC

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