Recalls / Class I
Class ID-0433-2015
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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).
- Brand name
- Mitoxantrone
- Generic name
- Mitoxantrone
- Active ingredient
- Mitoxantrone Hydrochloride
- Route
- Intravenous
- NDC
- 61703-343
- FDA application
- ANDA076871
- Affected lot / code info
- 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.
Why it was recalled
Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 13,792 Vials (U.S.)
- Distribution pattern
- US: Nationwide including Puerto Rico; Australia, Canada, Cyprus, Egypt, Ireland, Saudi Arabia, Qatar, Oman, Bahrain, and United Kingdom.
Timeline
- Recall initiated
- 2014-12-03
- FDA classified
- 2015-04-06
- Posted by FDA
- 2015-04-15
- Terminated
- 2016-12-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0433-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.