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Teva UK Limited
Glibenclamide 5mg Tablets (Teva UK Limited and Generics (UK) Limited Livery)
PL 00289/0048
Product in Teva UK Limited Livery
Batch number Expiry date Pack size First distributed
7T88HL November 2010 1x28 7 April 2008
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
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 First distributed
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 7540 7117.
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 |
