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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot: 0NCW005, Exp 02/2013
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-139-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 12, 2012
- FDA report date
- Feb 6, 2013
- Quantity
- 17,169 Packages
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Schering-Plough Products, LLC
Original FDA data
Every field from FDA enforcement report D-139-2013, exactly as published.
Show all FDA fields
- City
- Las Piedras
- State
- PR
- Status
- Terminated
- Country
- United States
- Event ID
- 63879
- Address
- Pridco Industrial Park
- Address (line 2)
- Road # 183
- Code information
- Lot: 0NCW005, Exp 02/2013
- Postal code
- 00771
- Report date
- Feb 6, 2013
- Product type
- Drugs
- Recall number
- D-139-2013
- Classification
- Class II
- Recalling firm
- Schering-Plough Products, LLC
- Product quantity
- 17,169 Packages
- Termination date
- Jan 3, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Dec 12, 2012
- Initial firm notification
- Letter
- Center classification date
- Jan 30, 2013