Amoxil Vials for injection 500mg and 1g, Augmentin Intravenous 600mg and 1.2g - cracks in vials used for packaging

(GlaxoSmithKline) Check each vial for cracks by turning upside down and looking for chips, cracks or damage where base meets side wall. (EL (14)A/15)

15 October 2014

Class 4 medicines defect information

Caution in use

MDR 50-09/14

Product details

Beecham Group PLC and Beecham Group Ltd trading as GlaxoSmithKline UK

Amoxil Vials for Injection 500mg:   PL 00038/0222
Amoxil Vials for Injection 1g:   PL 00038/0225
Augmentin Intravenous 600mg:   PL 00038/0320
Augmentin Intravenous 1.2g:   PL 00038/0320

Alert details

Product   Batch Number   Expiry Date   Pack Size   First Distributed
Amoxil 500mg   637179   18 Apr 2015   1 x 10   01/08/2013
Amoxil 500mg   644732   18 Apr 2015   1 x 10   08/11/2013
                 
Amoxil 1g   637276   18 Apr 2015   1 x 10   04/08/2013
                 
Augmentin 600mg   619927   28 Dec 2014   1 x 10   18/04/2013
Augmentin 600mg   629800   01 Jan 2015   1 x 10   31/05/2013
Augmentin 600mg   638735   10 Apr 2015   1 x 10   23/09/2013
Augmentin 600mg   648688   11 Apr 2015   1 x 10   15/11/2013
Augmentin 600mg   671149   17 Jul 2015   1 x 10   07/05/2014
Augmentin 600mg   671150   13 Nov 2015   1 x 10   25/04/2014
Augmentin 600mg   676171   02 Jan 2016   1 x 10   08/07/2014
                 
Augmentin 1.2g   622808   21 Nov 2014   1 x 10   19/04/2013
Augmentin 1.2g   629852   29 Jan 2015   1 x 10   10/06/2014
Augmentin 1.2g   633467   30 Jan 2015   1 x 10   03/07/2013
Augmentin 1.2g   640863   08 Nov 2014   1 x 10   19/09/2013
Augmentin 1.2g   647734   28 May 2015   1 x 10   07/02/2014
Augmentin 1.2g   663747   26 Jul 2015   1 x 10   10/04/2014

GlaxoSmithKline has informed us of a very low incidence of cracks being found in vials used for packaging of the above products. The cracks are positioned where the base of the vial meets the side wall and there are concerns that sterility may be breached in affected vials. Although the defect has to date been identified in a limited number of batches, all the above batches use the same type of vial and may potentially be affected.

In order to avoid product shortages, the above batches are not being recalled. Recipients of these batches are asked to check each vial for cracks prior to use by turning upside down and looking for chips, cracks or damage where the base meets the side wall. The contents of the vials should only be used if the solution is a colourless or pale straw coloured liquid upon reconstitution. If any cracked or discoloured vial is identified, please retain and contact GlaxoSmithKline Medical Information on 0800 221 441 to return product.

Please note: For Augmentin a transient pink colouration may or may not develop during reconstitution.

For Amoxiil, a transient pink colouration or slight opalescence may appear during reconstitution.

If you have any enquiries concerning this incident, please contact GlaxoSmithKline Medical Information, tel 0800 221 441 email customercontactuk@gsk.com

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter.

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