Why it was recalled
Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
Product description
TORISEL Kit (temsirolimus) injection, 25 mg/mL, CONCENTRATED, Rx Only, Packaged in a carton containing 1 vial TORISEL injection and 1 vial DILUENT for TORISEL, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA --- NDC 0008-1179-01
Lot numbers, UPCs & expiration codes
Lots P00025A; P00027B
Where it was sold
Nationwide
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-219-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 26, 2012
- FDA report date
- Apr 3, 2013
- Quantity
- 10920 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-219-2013, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 64690
- Address
- 235 East 42nd Street
- Code information
- Lots P00025A; P00027B
- Postal code
- 10017-5703
- Report date
- Apr 3, 2013
- Product type
- Drugs
- Recall number
- D-219-2013
- Classification
- Class III
- Recalling firm
- Pfizer Inc.
- Product quantity
- 10920 kits
- Termination date
- Mar 31, 2015
- Reason for recall
- Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- TORISEL Kit (temsirolimus) injection, 25 mg/mL, CONCENTRATED, Rx Only, Packaged in a carton containing 1 vial TORISEL injection and 1 vial DILUENT for TORISEL, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA --- NDC 0008-1179-01
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 26, 2012
- Initial firm notification
- Letter
- Center classification date
- Mar 26, 2013