Class 2 Drug Alert (Action within 48 hours): Athlone Laboratories Limited - Citalopram 10 mg and 20 mg Tablets in Kent Pharmaceuticals Limited livery - EL (10)A/19

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Dear Healthcare Professional,

Statement for consumers: Kent Pharmaceuticals Limited is recalling packs of 28 Citalopram 10 mg tablets embossed with the batch number IB10309, IB10409, IB10509 or IB10609. This is because in a very small number of cases, 20 mg blisters with the same batch number have been packed in 10 mg cartons. Two reports have been received to date and from the evidence available these appear to be isolated cases. This could mean, however, that some people may have a 10 mg carton at home and the blister pack inside is 20 mg. They should go and exchange this at their pharmacist. If people have taken the stronger dose and are feeling unwell, then they should contact their doctor or go to their local casualty department.

 

Batch number	Expiry date	Pack size	First distributed
IB10309	Aug 2012	28	07 Jul 2010
IB10409	Sept 2012	28	07 Jul 2010
IB10509	Sept 2012	28	05 Jul 2010
IB10609	Sept 2012	28	20 Jul 2010

Kent Pharmaceuticals Limited has informed the MHRA that in a very small number of cases, Citalopram 10 mg cartons contain Citalopram 20 mg blisters with the same batch number. These packs will have been supplied as overwrapped packs of ten Citalopram 20 mg cartons. An overwrap could inadvertently include Citalopram 10 mg cartons.

Pharmacists are asked to check the batch numbers of stocks of Citalopram 10 mg. Any 10 mg cartons embossed with the batch number IB10309, IB10409, IB10509 or IB10609 should be quarantined and returned via the original supplier for credit.

Pharmacists are also asked to check all unopened, overwrapped packs of ten Citalopram 20 mg, from batches IB10309, IB10409, IB10509 or IB10609, for any 10 mg Citalopram cartons. Any found should be quarantined and returned via the original supplier for credit.

For stock return enquiries, please contact Kent Pharmaceuticals Customer Services on 0800 220280. For Medical Information enquiries, please contact 01233 616474.

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)