To:	MHRA Drug Alerts Primary Care Trusts - Directors of Public Health Primary Care Trusts - Medical Directors Public Health Link
Cc (Groups):	Chairman - Professional Executive Committee of PCT Regional Directors of Public Health Strategic Health Authorities (England) - Directors of Public Health Territorial CMOs
Fax To:
From:	Ian Holloway - Medicines and Healthcare Products Regulatory Agency
Date:	18 January 2006
Reference	EL(06)A/05
Category:	Action within 48 hours
Title:	DRUG ALERT CLASS 2 MEDICINES RECALL - POLYFARMA LTD - TEGRETOL RETARD TABLETS 400MG (CARBAMAZEPINE) - PARALLEL IMPORT

Broadcast Content:

MHRA Defective Medicines Report Centre
Market Towers
1 Nine Elms Lane
London SW8 5NQ
Tel: 020 7084 2574 Fax 020 7084 2676

D R U G A L E R T
CLASS 2 MEDICINES RECALL

Action Within 48 Hours
PHARMACY (or equivalent) LEVEL RECALL

Date 18th January 2006

EL(06)A/05

OUR REF: MDR 28-01/06

Dear Healthcare Professional,

TEGRETOL RETARD TABLETS 400MG (PARALLEL IMPORT) CARBAMAZEPINE

PL 17211/0242

Batch Number	Expiry Date	Pack Size	First Distributed
T5514	02/2008	30	19/10/2005
T5541	04/2008	30	16/11/2005

Polyfarma Ltd are recalling the above batches as the blister strips inside the carton are incorrectly overlabelled as Tegretol in place of Tegretol Retard. We have been informed that there are no errors in the carton labelling.

The SPC states that Tegretol Retard tablets are not recommended for children under 5 years and highlights several other concerns in switching patients between these formulations.

Recipients are requested to quarantine any remaining stock and return it to their supplier for credit.

For all queries relating to stock return, please call Polyfarma Customer Services on0800 220280.

For medical enquiries please contact Debbie Ward at Polyfarma on 01233 638614.

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

Ian Holloway, DMRC Manager

Please note:a reference copy is also attached in Word format: