Clarithromycin 500mg Powder for Solution for Infusion - small particles of white material to be present in individual vials

(Mylan on behalf of Strides Arcolab International Limited) Remaining stocks of affected batches should be quarantined - class 2 action within 48 hours. (EL (14)A/07)

18 June 2014

Class 2 medicines recall

Action within 48 hours

Hospital ward, hospital pharmacy, clinic and wholesale-level recall

MDR 17-06/14

Product details

Strides Arcolab International Limited

Clarithromycin 500mg Powder for Solution for Infusion in Agila livery

PL 28176/0084

Alert details

Batch number   Expiry date   Pack size   First distributed
5000743   Jul 2014   1 x 10ml   Dec 2012
5000765   Sep 2014   1 x 10ml   Dec 2012
5000930   Dec 2014   1 x 10ml   Feb 2013
5000951   Jan 2015   1 x 10ml   Mar 2013
5000965   Jan 2015   1 x 10ml   Mar 2013
5001003   Feb 2015   1 x 10ml   Apr 2013
5001057   Apr 2015   1 x 10ml   Jun 2013
5001085   Apr 2015   1 x 10ml   Jun 2013
5001090   May 2015   1 x 10ml   Jul 2013
5001132   May 2015   1 x 10ml   Sep 2013
5001141   Jun 2015   1 x 10ml   Nov 2013
5001159   Jun 2015   1 x 10ml   Jan 2014
5001170   Jul 2015   1 x 10ml   Nov 2013
5001338   Nov 2015   1 x 10ml   Feb 2014

Mylan is recalling all remaining stock of the above batches on behalf of Strides Arcolab International Limited due to the potential for small particles of white material to be present in individual vials.

Remaining stocks of the affected batches should be quarantined. For stock enquiries and to arrange uplift, please contact Mylan Customer Services by telephone on 01707 853215 or email carolyn.pepper@mylan.co.uk.

For medical information enquiries please contact Agila Clinical Affairs Department by email: francis.michael@mylan.com or maneesh.sarvi@mylan.com.

Recipients of this drug alert should bring it to the attention of relevant contacts by copy of this letter.

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