Class 2 Drug Alert (Action within 48 hours): Pharmacosmos A/S - CosmoFer 50mg/ml solution for infusion and injection

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Dear Healthcare Professional,

CosmoFer 50mg/ml solution for infusion and injection
2 ml and 10ml ampoules containing Iron(III)-as Iron(III)-hydroxide dextran complex

Batch Number	Expiry Date	Pack Size	First Distributed
0546093-4	11/2008	5 X 2ml ampoules	May 2006
0635271-5	8/2009	5 X 2ml ampoules	February 2007
0702746-1	12/2009	5 X 2ml ampoules	March 2007
0710176-1	3/2010	5 X 2ml ampoules	July 2007
0714183-2	3/2010	5 X 2ml ampoules	December 2007
0727853-3	6/2010	5 X 2ml ampoules	January 2008
0734209-1	8/2010	2 X 10ml ampoules	March 2008
0734209-4	8/2010	2 X 10ml ampoules	September 2008
0749461-2	11/2010	5 X 2ml ampoules	June 2008

Pharmacosmos A/S are recalling all remaining stock of the above batches due to a potential risk of formation of precipitate in the solution.

We understand this product is mainly used in hospitals but some product is supplied via Community Pharmacies.

All unused stock of the above batches should be quarantined and returned for credit via the original supplier. For returns and credit enquiries, please contact the Uk distributor Vitaline Ltd on 01844 269007

Medical information can be obtained from the UK distributor, Vitaline Ltd on 01844 269007.

Recipients of this Drug Alert should bring this to the attention of relevant contacts by copy of this letter. Primary Care Trusts are asked to bring this to the attention of relevant clinics, General Practitioners and Community Pharmacists by copy of this letter.

Yours faithfully
Ian Holloway
MHRA DMRC Manager

MHRA Distribution (further recipients by cascade):
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)