Vancomycin Powder for Concentrate for Solution for Infusion - small particles of fibre material and glass in individual vials

(ITH Pharma Ltd) Remaining stocks should be quarantined and returned to original supplier for credit - class 2 action within 48 hours. (EL (14)A/06)

12 June 2014

Class 2 medicines recall

Action within 48 hours

Hospital ward, pharmacy, clinic and wholesale level

MDR 16-06/14

Product details

Actavis Group PTC ehf

Vancomycin Powder for Concentrate for Solution for Infusion 500mg - PL 30306/0444

Vancomycin Powder for Concentrate for Solution for Infusion 1000mg - PL 30306/0445

Alert details

Product Batch number Expiry date First distributed
Vancomycin Powder for Infusion 500mg   5001039   Mar-2015   26-Jun-2013
5001066   Apr-2015   15-Jul-2013    
5001177   Jul-2015   13-Sep-2013    
5001231   Aug-2015   16-Dec-2013    
5000830   Oct-2014   14-Feb-2013    
Vancomycin Powder for Concentrate for Solution for Infusion 1000mg   5001102   May-2015   18-Sep-2013
5001128   Jun-2015   27-Dec-2013    
5001034   Mar-2015   17-Oct-2013    
5001190   Jul-2015   27-May-2014    

Actavis is recalling all remaining stock of the above batches to hospital ward, pharmacy, clinic and wholesale level. This is due to the potential for small particles of fibre material and glass to be present in individual vials, identified by Actavis’ third party manufacturer.

Remaining stocks of the affected batches should be quarantined and returned to the original supplier for credit. For enquiries relating to stock returns please contact Actavis Customer Services on 0800 373 573.

For medical information enquiries please contact Actavis Medical Information Department on 01271 385 257.

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

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Published 17 December 2014