Class 3 Drug Alert (Action Within 5 Days) Teva UK Limited, Alendronic Acid 10mg Tablets - Batch recall due to out of specification assay results – EL(12)A/06 – PL 00289/0703
Class 3 - Action Within 5 Days

Publisher: Defective Medicines Report Centre

Date published: 09/02/2012 11:29

Summary
by: Alison Bunce

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.

About this library entry
Category: Drug Alerts

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