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 |