Why it was recalled
Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
Product description
MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only. Hospira, Lake Forest, IL 60045, Product of Australia. Available in a) 20 mg/10 mL Multi Dose Vial (NDC: 61703-343-18); b) 25 mg/12.5 mL Multi Dose Vial (NDC: 61703-343-65); c) 30 mg/15 mL Multi Dose Vial (NDC: 61703-343-66).
Lot numbers, UPCs & expiration codes
LOTS DISTRIBUTED IN THE UNITED STATES: a) Lot: Z054636AA, Expiry: December 2014; Lot: A014636AA, Expiry: April 2015; Lot: A024636AB, Expiry: July 2015. b) Lot: A014645AA, Expiry: November 2015. c) Lot: A014643AA, Expiry April 2015.
Where it was sold
US: Nationwide including Puerto Rico; Australia, Canada, Cyprus, Egypt, Ireland, Saudi Arabia, Qatar, Oman, Bahrain, and United Kingdom.
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-0433-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 3, 2014
- FDA report date
- Apr 15, 2015
- Quantity
- 13,792 Vials (U.S.)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-0433-2015, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 70064
- Address
- 275 N Field Dr
- Code information
- LOTS DISTRIBUTED IN THE UNITED STATES: a) Lot: Z054636AA, Expiry: December 2014; Lot: A014636AA, Expiry: April 2015; Lot: A024636AB, Expiry: July 2015. b) Lot: A014645AA, Expiry: November 2015. c) Lot: A014643AA, Expiry April 2015.
- Postal code
- 60045-2579
- Report date
- Apr 15, 2015
- Product type
- Drugs
- Recall number
- D-0433-2015
- Classification
- Class I
- Recalling firm
- Hospira Inc.
- Product quantity
- 13,792 Vials (U.S.)
- Termination date
- Dec 2, 2016
- Reason for recall
- Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only. Hospira, Lake Forest, IL 60045, Product of Australia. Available in a) 20 mg/10 mL Multi Dose Vial (NDC: 61703-343-18); b) 25 mg/12.5 mL Multi Dose Vial (NDC: 61703-343-65); c) 30 mg/15 mL Multi Dose Vial (NDC: 61703-343-66).
- Distribution pattern
- US: Nationwide including Puerto Rico; Australia, Canada, Cyprus, Egypt, Ireland, Saudi Arabia, Qatar, Oman, Bahrain, and United Kingdom.
- Recall initiation date
- Dec 3, 2014
- Initial firm notification
- Letter
- Center classification date
- Apr 6, 2015