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DRUG ALERT
CLASS 2 MEDICINES RECALL
Action Within 48 Hours
PHARMACY OR EQUIVALENT LEVEL RECALL
PHARMACY OR EQUIVALENT LEVEL RECALL
| 05 November 2009 | EL (09)A/28 | Our ref: MDR 71-10/09 |
Dear Healthcare Professional,
Abraxis BioScience Ltd
Abraxane 5mg/ml powder for suspension for infusion
Paclitaxel Albumin
EU/1/07/428/001
| Batch Number | Expiry Date | Pack Size | First Distributed |
|
405692A |
12/2009 | Single 50 ml vials | 12/2008 |
Abraxis BioScience Ltd are recalling all remaining stock of the above batch as a precautionary measure. Particulate matter has been found in other batches of Abraxane made in the same time period.
Medical Information enquiries should be telephoned to 0207 081 0850.
Please quarantine any remaining stocks of this batch. Recipients will be contacted by Aexxdis (the appointed distributor) and given instructions for stock returns. For any related enquiries, please telephone Aexxdis on 05603 141 956.
Supplies of the licensed UK presentation of Abraxane are not expected to return to normal until the end of Q1 2010.
A Dear Healthcare Professional (DHCP) letter is being distributed by Abraxis to physicians which will recommend that patients are switched to alternate therapies if judged clinically acceptable.
For any patients who cannot be switched to other products, imports of unlicensed Abraxane are being permitted. Unlicensed packs will not be labelled in accordance with the normal UK format and the prescriber accepts responsibility for their use in the best clinical interests of the patient.
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Primary Care Trusts are asked to forward this to relevant clinics and to General Practitioners and Community Pharmacists for information.
Yours faithfully
Ian Holloway, MHRA DMRC Manager
Regional Contacts for NHS Trusts and Provider Units
Chief Pharmacists: England, Scotland, Wales, Northern Ireland
Prison Health Policy Unit (DH)
Chief Pharmacists: Jersey, Guernsey, Alderney, Sark, Isle of Man, Gibraltar
Special Hospitals
Healthcare Commission for distribution to Independent Health Care Establishments
Primary Care Trusts (England)
Class 2 Drug Alert (Action within 48 hours): Abraxis BioScience Ltd - Abraxane 5mg/ml powder for suspension for infusion - EL (09)A/28 
