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Class 3 Drug Alert: Teva UK Limited - Alendronic Acid 10mg Tablets - EL(12)A/06

Document details:

Type: Drug Alert
Series No: EL(12)A/06
Audience: Healthcare professionals
Published:
Format: Electronic image
Size: A4
Pages: 1
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

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DRUG ALERT

CLASS 3 MEDICINES RECALL

Action within 5 days


PHARMACY LEVEL RECALL

09 February 2012 EL(12)A/06 Our ref: 

MDR 29-01/12


Dear Healthcare Professional,

Teva UK Limited

Alendronic Acid 10mg Tablets

PL 00289/0703
 

Batch Number Expiry Date Pack Size First Distributed
006829 Mar 2014 1 x 28 23 May 2011

Teva UK Limited is recalling the above batch because, during non-routine testing 10 months after manufacture, some samples were found to be marginally out of specification for assay. This finding is not expected to impact on patient safety at this stage but there are concerns about potential effects on potency of the batch during the remainder of the shelf-life.

Remaining stocks of this batch 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: 09 February 2012