Reported Apr 15, 2015 · Terminated
MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only. Hospira, Lake Forest, IL 60045, Product of Australia.…
Hospira Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hospira Inc. · 275 N Field Dr · Lake Forest, IL · 60045-2579
Is this the product you have?
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
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 61703-343-18) |
| 2 | 25 mg/12.5 mL Multi Dose Vial (NDC: 61703-343-65) |
| 3 | 30 mg/15 mL Multi Dose Vial (NDC: 61703-343-66). |
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 1 Lot: Z054636AA, Expiry: December 2014; Lot: A014636AA, Expiry: April 2015; Lot: A024636AB, Expiry: July 2015. 2 Lot: A014645AA, Expiry: November 2015. 3 Lot: A014643AA, Expiry April 2015. - Amount recalled
- 13,792 Vials (U.S.)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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