Hospira Recalls MitoXANTRONE Injection Due to Stability Failures
Hospira Inc. is recalling MitoXANTRONE Injection vials because the product failed stability specifications, resulting in subpotent medication and out-of-specification impurities.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
Hospira Inc. is recalling MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, a prescription-only intravenous medication. The recall involves 13,792 vials distributed in the United States, including Puerto Rico, as well as in Australia, Canada, Cyprus, Egypt, Ireland, Saudi Arabia, Qatar, Oman, Bahrain, and the United Kingdom.
The recall was initiated because the product failed stability specifications. Specifically, the medication is subpotent and contains out-of-specification known and unknown impurities. The affected lots include Z054636AA, A014636AA, A024636AB, A014645AA, and A014643AA, with expiry dates ranging from December 2014 to November 2015.
Healthcare providers and patients should stop using the affected vials and contact Hospira Inc. for further instructions. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- MITOXANTRONE (MITOXANTRONE)
- Brand
- MITOXANTRONE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Antineoplastic
- Hazard
- Affected units
- 13,792
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 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.
Distribution
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