Hospira Announces Voluntary Recall Due to Subpotency and Impurity Levels

December 30, 2014

Hospira issued a voluntary worldwide recall due to confirmed subpotency and elevated impurity levels.

 

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 ProductComplaintsPP@hospira.com.

For medical inquiries, please contact Hospira Medical Communications 24 hours a day Monday through Sunday at 1.800.615.0187 or email them at medcom@hospira.com.

Source: FDA