Gene-corrected nula-cel freed all 3 RESTORE patients from transfusions, with sickle hemoglobin below 20% in the 2 followed for over 6 months.
|Articles|December 30, 2014
Hospira Announces Voluntary Recall Due to Subpotency and Impurity Levels
Author(s)BioPharm International Editors
Hospira issued a voluntary worldwide recall due to confirmed subpotency and elevated impurity levels.
Advertisement
Hospira announced on Dec. 23, 2014 that it issued a voluntary recall of 10 lots of Mitoxantrone, for both human and veterinary use, due to confirmed subpotency and elevated impurity levels. Risk factors due to this recall may include potential for decreased potency leading to decreased effectiveness, additional dosing, and the potential for cumulative impurity toxicity requiring medical intervention.
There have not been any reported adverse events associated with this recall. Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately.
The recall, which is for lots distributed to hospitals and veterinary clinics worldwide from February 2013 to November 2014, affects the following lots:
United States
- Mitoxantrone injection, lot numbers: Z054636AA (exp. 12/14), A014636AA (exp. 4/15), A024636AB (exp. 7/15), A014643AA (exp. 4/15), A014645AA (exp. 11/15)
Australia and New Zealand
- Mitoxantrone hydrochloride injection, batch number A024636AA (exp. 7/15)
Canada
- Mitoxantrone for injection, lot number A024636AC (exp. 7/15)
United Kingdom, Ireland, Cyprus, Saudi Arabia, Qatar, Oman, and Bahrain
- Mitoxantrone concentrate for infusion, lot numbers: A014636AB (exp. 4/15), A024636AD (exp. 7/15), Z054636AB (exp. 12/14).
To report adverse events or product complaints, please contact Hospira Global Complaint Management, Monday through Friday, 8 AM to 5 PM CT at 1.800.441.4100 or email them at
For medical inquiries, please contact Hospira Medical Communications 24 hours a day Monday through Sunday at 1.800.615.0187 or email them at
Source:
Advertisement
Related to this article
This FAQ explains how aseptic processing, contamination control, and validation protect patients amid sterile injectable failures.
Johnson & Johnson's amivantamab (Rybrevant Faspro) won accelerated FDA approval for pretreated recurrent head and neck cancer.
FDA’s draft framework would let sponsors add patient-specific genome editing variants to an approved BLA using in vitro data. Here is what the guidance proposes, what evidence it asks for, and what remains unresolved.
Akeso won NMPA priority review for ivonescimab plus chemotherapy in first-line biliary tract cancer after a phase 3 win over durvalumab plus chemo.
VG801 gene therapy improved vision through 12 months in a Stargardt disease trial as VeonGen aligned with FDA on its pivotal phase 3 design.
As access to low Earth orbit expands, space-based research is opening possibilities in drug discovery, formulation, and manufacturing. In Part 1, the authors look at how microgravity changes biology and chemistry in ways that can’t be reproduced on Earth and where it fits from target discovery to life cycle management.
Detalimogene voraplasmid produced a 56% complete response rate in BCG-unresponsive bladder cancer, with an estimated 43% of responses lasting a year.
Advertisement
Advertisement
Trending on BioPharm International
1
ImvivaBio’s Dual-Target Allogeneic CAR-T Sustains Lupus Remission Through 12 Months
2
Blackstone to Provide Pfizer Up to $1.5 Billion for Monthly GLP-1 Berobenatide Development
3
Updates on Simtra BioPharma Solutions’ Bloomington Capacity Expansions
4
The BioPharm Brief: An AI-Designed Multibody ADC Enters the Clinic, Blackstone Backs Pfizer’s Monthly GLP-1, and enGene Readies a Bladder Cancer BLA
5