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
0NCW005Exp 02/2013
- Lot
- 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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