Class 3 Drug Alert (Action within five days): Teva UK Limited - Glibenclamide 5 mg Tablets in Teva UK Limited and Generics (UK) Limited Livery - EL (10)A/06 Rev 1

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Dear Healthcare Professional,

Product in Teva UK Limited Livery

Batch number	Expiry date	Pack size	First distributed
7T88HL	November 2010	1x28	7 April 2008
8G04HLB	June 2011	1x28	26 March 2009
8G05HL	June 2011	1x28	9 September 2008
9A06HL	January 2012	1x28	16 April 2009
9A08HL	January 2012	1x28	7 August 2009
000132	March 2012	1x28	28 September 2009

 

Product in Generics (UK) Limited Livery

Batch number	Expiry date	Pack size	First distributed
7T01HL	November 2010	1x28	31 March 2008
8G04HL	June 2011	1x28	22 September 2008
8G05HL	June 2011	1x28	29 September 2008
9A08HLA	January 2012	1x28	27 April 2009
000536	January 2012	1x28	9 November 2009

Please replace the Drug Alert issued on 9 March 2010 with this revised document.

Teva UK limited has informed us that one additional batch in Teva UK Limited livery, and two additional batches in Generics (UK) Limited livery, are involved in the recall. Details have been added to the tables, above. The Company apologises for any additional inconvenience this may cause.

Teva UK Limited are recalling all remaining stock of the above batches as a precautionary measure because routine stability testing has indicated that the specification for tablet dissolution may not be met after 12 months from manufacture. All batches which may be non-compliant were manufactured using a single batch of active ingredient.

In order to avoid market shortages, batches with an expiry date of September 2012 or later will remain on the market until replacement stock is available. This is expected by the end of May. Please see details of batches remaining on the market in the table below:

Batch number	Expiry date	Pack size	Livery
000537	September 2012	1x28	Teva UK Limited
000681	September 2012	1x28	Generics (UK) Limited
001315	September 2012	1x28	Teva UK Limited

For medical information enquiries, please contact Teva UK Limited on 020 75407117.

Remaining stocks of the batches which are being recalled should be returned to the original wholesaler for credit. For further stock enquiries please contact Teva UK Customer Liaison Team on 0800 590502.

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)