Why it was recalled
Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold storage. The TORISEL vials are not affected by this issue.
Product description
TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TORISEL 25 mg/mL and 1 vial of 2.2 mL DILUENT per carton, Rx only, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101; Diluent MADE IN ITALY; NDC 0008-1179-01.
Lot numbers, UPCs & expiration codes
Kit Lot #: AIEM/13, Exp 05/16 that contain diluent lots AHZW/11 and AHZW/12
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-0235-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 10, 2014
- FDA report date
- Nov 12, 2014
- Quantity
- 16,000 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0235-2015, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 69479
- Address
- 235 East 42nd Street
- Code information
- Kit Lot #: AIEM/13, Exp 05/16 that contain diluent lots AHZW/11 and AHZW/12
- Postal code
- 10017-5703
- Report date
- Nov 12, 2014
- Product type
- Drugs
- Recall number
- D-0235-2015
- Classification
- Class III
- Recalling firm
- Pfizer Inc.
- Product quantity
- 16,000 kits
- Termination date
- Apr 14, 2017
- Reason for recall
- Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold storage. The TORISEL vials are not affected by this issue.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TORISEL 25 mg/mL and 1 vial of 2.2 mL DILUENT per carton, Rx only, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101; Diluent MADE IN ITALY; NDC 0008-1179-01.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Oct 10, 2014
- Initial firm notification
- Letter
- Center classification date
- Nov 4, 2014