Warfarin 3mg tablets - higher than expected levels of degradation

(Teva UK Limited) Remaining stock should be quarantined and returned to original supplier for credit – class 3 action within 5 days. (EL (13) A/21)

01 August 2013

Class 3 medicines recall

Action within 5 days

Pharmacy-level recall

MDR 78-02/13

Product details

Teva UK Limited

Warfarin 3mg Tablets in Teva UK and Lloyds Pharmacy liveries

PL 00289/1628

Alert details

Teva UK Limited is recalling all remaining stock of the batches listed in the attached tables because higher than expected levels of degradation products were detected during routine stability studies. Although there are currently no concerns relating to patient safety, it is possible that degradation products may exceed specification towards the end of the shelf-life.

Remaining stock of these batches should be quarantined and returned to the original supplier for credit. This action should not result in stock shortages because new batches, with a reduced shelf-life, have recently been released to the market. For further stock enquiries please contact Teva UK Customer Service Team on 0800 590502.

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

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Local area teams are asked to forward this to relevant clinics, general practitioners and community pharmacists for information.

Product in Teva UK Limited Livery

Batch number   Expiry date   Pack size   First distributed
007919   30 March 2016   28 (2 x 14)   22 September 2011
007920   31 March 2016   28 (2 x 14)   18 September 2011
008426   31 March 2016   28 (2 x 14)   31 October 2011
008427   30 June 2016   28 (2 x 14)   31 October 2011
008772   30 June 2016   28 (2 x 14)   13 December 2011
009101   30 September 2016   28 (2 x 14)   2 February 2012
009483   31 October 2016   28 (2 x 14)   19 March 2012
009484   31 December 2016   28 (2 x 14)   19 March 2012
010019   31 December 2016   28 (2 x 14)   14 May 2012
010022   31 December 2016   28 (2 x 14)   14 May 2012
010510   31 January 2017   28 (2 x 14)   27 June 2012
010755   31 March 2017   28 (2 x 14)   6 August 2012
011117   31 May 2017   28 (2 x 14)   18 September 2012
011609   31 May 2017   28 (2 x 14)   23 October 2012
011610   31 July 2017   28 (2 x 14)   23 October 2012
012450   31 August 2017   28 (2 x 14)   31 January 2013
012451   31 October 2017   28 (2 x 14)   31 January 2013
012452   31 October 2017   28 (2 x 14)   31 January 2013
012453   31 October 2017   28 (2 x 14)   31 January 2013
012454   30 November 2017   28 (2 x 14)   31 January 2013
012966   31 December 2017   28 (2 x 14)   15 April 2013

Product in Lloyds Pharmacy Livery

Batch number   Expiry date   Pack size   First distributed
007917   31 July 2015   28 (2 x 14)   18 September 2011
007335   31 December 2015   28 (2 x 14)   6 July 2011
007336   31 March 2016   28 (2 x 14)   6 July2011
007554   31 March 2016   28 (2 x 14)   3 August 2011
007918   31 March 2016   28 (2 x 14)   18 September 2011
007919   31 March 2016   28 (2 x 14)   18 September 2011
009512   31 March 2016   28 (2 x 14)   19 March 2012
008395   30 June 2016   28 (2 x 14)   11 November 2011
008773   31 July 2016   28 (2 x 14)   14 December 2011
009074   31 July 2016   28 (2 x 14)   24 January 2012
009511   30 September 2016   28 (2 x 14)   19 March 2012
009513   31 October 2016   28 (2 x 14)   19 March 2012
009514   31 October 2016   28 (2 x 14)   19 March 2012
010283   31 January 2017   28 (2 x 14)   30 May 2012
010822   31 January 2017   28 (2 x 14)   26 July 2012
011118   31 May 2017   28 (2 x 14)   4 October 2012
011899   31 July 2017   28 (2 x 14)   21 November 2012
011900   31 August 2017   28 (2 x 14)   21 November 2012
012463   30 November 2017   28 (2 x 14)   31 January 2013
012464   30 November 2017   28 (2 x 14)   31 January 2013
012465   30 November 2017   28 (2 x 14)   31 January 2013

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