Class 3 Drug Alert (Action within 5 days): Schering-Plough Ltd - IntronA 18, 30 and 60 million IU solution for injection (Recombinant interferon alfa-2b) - EL (10)A/02

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Dear Healthcare Professional,

IntronA 18 million IU solution for injection	EU/1/99/127/031-033
IntronA 30 million IU solution for injection	EU/1/99/127/034-036
IntronA 60 million IU solution for injection	EU/1/99/127/037-039

(Recombinant interferon alfa-2b)

 

Presentation	Batch Number	Expiry Date	First Distributed
IntronA 18MIU Multidose Pen	9IOL10504	Oct 2010	14 Jul 2009
IntronA 18MIU Multidose Pen	9IOL10609	Nov 2010	14 Sep 2009
IntronA 30MIU Multidose Pen	9IOK40308	Oct 2010	01 Oct 2009
IntronA 30MIU Multidose Pen	9IOK40328	Oct 2010	22  Dec 2009
IntronA 60MIU Multidose Pen	9IOM70212	Sep 2010	01 Oct 2009
IntronA 60MIU Multidose Pen	9IOM70316	Sep 2010	23 Nov 2009

Schering-Plough Ltd is recalling the above batches, which have an expiry date of 18 months, as a precautionary measure because the stability of the products after 15 months cannot be assured. All new batches are labelled with a 15 month expiry date and are being supplied through normal wholesaler channels.

Pharmacists are asked to quarantine any remaining stocks from these batches. Schering-Plough Ltd is writing to wholesalers and hospital pharmacies that may have received these batches and is providing them with instructions on how to return any stock. If you have stock from these batches, and have not heard from Schering-Plough Ltd within five days from receipt of this letter, please either telephone or email Customer Care, tel 01707 36375; email UKCustomercare@spcorp.com.

For Medical Information enquiries, please telephone Schering-Plough Ltd on 01707 363636

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

Alison Bunce
Pharmaceutical Assessor, DMRC

 

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)