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Class 3 Drug Alert (Action within 5 days): Glibenclamide 5 mg Tablets in Teva UK Limited and Generics (UK) Limited Livery - EL (10)A/17

Document details:

Type: Drug Alert
Series No: EL (10)A/17
Audience: Healthcare professionals
Published:
Format: Electonic and paper
Size: A4
Pages: 2
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.

DRUG ALERT

CLASS 3 MEDICINES RECALL
Action within 5 days
PHARMACY LEVEL RECALL
12 July 2010 EL (10)A/17 Our ref:  MDR 59-01/10

Dear Healthcare Professional,

Teva UK Limited and Generics (UK) Limited

Glibenclamide 5 mg Tablets in 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
  000537  September 2012  1x28  18 Nov 2009
  001315  September 2012  1x28  11 Mar 2010

Product in Generics (UK) Limited Livery

  Batch Number  Expiry Date  Pack Size  First Distributed
  000681 September 2012  1x28 23 Nov 2009


Further to the Drug Alert issued by the MHRA on 15 March 2010 (EL (10)A/06 Rev 1) concerning the recall of some batches of this product due to issues with tablet dissolution during routine stability testing, Teva UK Limited has informed us that it has now received new stock. The three batches which remained on the market at the time in order to avoid market shortages are now being recalled by the company, see details in the tables above.

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

For medical information enquiries please contact Teva UK Limited by phone on 0207 5407117 or by email at medinfo@tevauk.com

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)

Page last modified: 22 November 2010