- Medicines and Healthcare products Regulatory Agency
- 15 October 2014
- Alert type:
- Drug alert
- Medical specialty:
(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
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|
|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 firstname.lastname@example.org
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter.
Issued: 15 October 2014
Alert type: Drug alert
Medical specialty: Pharmacy