DRUG ALERT
Class 2 medicines recall
Action Within 48 Hours
Hospital Pharmacy Level Recall
| 25 November 2014 | EL (14)A/17 | Our ref: MDR 40-11/14 |
|---|
Dear Healthcare Professional,
Hospira UK Limited
Mitoxantrone
PL 04515/0127
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| Z054636AB | Dec 2014 | 1 x 10ml | 18 Feb 2013 |
| A014636AB | Apr 2015 | 1 x 10ml | 14 Oct 2013 |
| A024636AD | Jul 2015 | 1 x 10ml | 31 Mar 2014 |
Hospira UK Limited is recalling the above batches due to a number of confirmed out of specification test results obtained during stability studies. The out of specification results relate to both adverse impurity profile and low potency.
Remaining stock of the affected batches should be quarantined. Hospira will contact customers who may have received the impacted batches to arrange collection via their primary wholesaler, Movianto. For enquiries relating to stock return, please contact the Hospira UK Customer service team, tel: 0800 0287304; email: custserv@hospira.com.
For medical information enquiries, please contact the Hospira medical information team, tel: 01926 83440; fax: 01926 834446; email: medinfouk@hospira.com.
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter.
Yours faithfully
Alison Bunce
Pharmaceutical Assessor
Defective Medicines Report Centre
151 Buckingham Palace Road
London
SW1W 9SZ
Telephone +44 (0)20 3080 65