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 | Ìý | Jul 2014 | Ìý | 1 x 10ml | Ìý | Dec 2012 |
| 5000765 | Ìý | Sep 2014 | Ìý | 1 x 10ml | Ìý | Dec 2012 |
| 5000930 | Ìý | Dec 2014 | Ìý | 1 x 10ml | Ìý | Feb 2013 |
| 5000951 | Ìý | Jan 2015 | Ìý | 1 x 10ml | Ìý | Mar 2013 |
| 5000965 | Ìý | Jan 2015 | Ìý | 1 x 10ml | Ìý | Mar 2013 |
| 5001003 | Ìý | Feb 2015 | Ìý | 1 x 10ml | Ìý | Apr 2013 |
| 5001057 | Ìý | Apr 2015 | Ìý | 1 x 10ml | Ìý | Jun 2013 |
| 5001085 | Ìý | Apr 2015 | Ìý | 1 x 10ml | Ìý | Jun 2013 |
| 5001090 | Ìý | May 2015 | Ìý | 1 x 10ml | Ìý | Jul 2013 |
| 5001132 | Ìý | May 2015 | Ìý | 1 x 10ml | Ìý | Sep 2013 |
| 5001141 | Ìý | Jun 2015 | Ìý | 1 x 10ml | Ìý | Nov 2013 |
| 5001159 | Ìý | Jun 2015 | Ìý | 1 x 10ml | Ìý | Jan 2014 |
| 5001170 | Ìý | Jul 2015 | Ìý | 1 x 10ml | Ìý | Nov 2013 |
| 5001338 | Ìý | Nov 2015 | Ìý | 1 x 10ml | Ìý | 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 [email protected].
For medical information enquiries please contact Agila Clinical Affairs Department by email: [email protected] or [email protected].
Recipients of this drug alert should bring it to the attention of relevant contacts by copy of this letter.