Tixylix® liquid medicines - small pieces of plastic being found in medicine

(Novartis Consumer Health UK Ltd) Fault with tamper seal on might result in small pieces of plastic being found in medicine. Class 2 action within 48 hours (EL (13)A/30)

From:
Medicines and Healthcare products Regulatory Agency
Published
17 December 2014
Message type:
Medicines recall/notification
Medical specialty:
Pharmacy
Issued:
13 December 2013

13 December 2013

Class 2 medicines recall

Action within 48 hours

Patient-level recall

MDR 47-11/13

Product details

Novartis Consumer Health UK Ltd

Tixylix Toddler Syrup 100ml - PL 00030/0150
(Glycerol)

Tixylix Toddler Syrup 150ml - PL 00030/0150
(Glycerol)

Tixylix Baby Syrup 100ml - PL 00030/0150
(Glycerol)

Tixylix Blackcurrant Flavour Syrup 100ml - PL 00030/0150
(Glycerol)

Tixylix Chesty Cough 100ml PL 00030/0082
(Guaifenesin)

Alert details

Novartis Consumer Health UK Ltd have been alerted to a potential manufacturing fault with the tamper seal on some Tixylix® liquid medicines which might result in small pieces of plastic being found in the medicine. This potential defect only affects specific batches of Tixylix manufactured from October 2012 onwards and as a precautionary measure these batches are being recalled to patient level. The specific batches subject to recall are listed in the table below.

No evidence of defective products has been identified in the market, and there have been no reports of adverse events.

Pharmacists and retailers are asked to quarantine all unexpired stock of the product and return it to their original supplier for credit

Consumers are asked to contact Novartis Consumer Health on 0800 854 100 or tixylix.co.uk for details on how to return a product.

For medical information queries and questions relating to the recall, please contact Novartis Consumer Health on 0800 854 100.

As the majority of these products are GSL medicines, this notification will be supported by press notifications by the marketing authorisation holder and the MHRA.

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Local area teams are asked to forward this to relevant clinics, general practitioners and community pharmacists for information.

Affected batches

Tixylix Chesty Cough 100ml

Batch number Expiry date Pack size First distributed
1RR   01/08/15   1 x 100ml   26/02/2013
1TT   01/05/16   1 x 100ml   25/11/2013
2RR   01/08/15   1 x 100ml   26/02/2013

Tixylix Toddler Syrup 100ml

Batch number Expiry date Pack size First distributed
10SS2   01/02/16   1 x 100ml   14/06/2013
11SS   01/02/16   1 x 100ml   17/06/2013
12RR   01/11/15   1 x 100ml   13/02/2013
13RR   01/11/15   1 x 100ml   08/03/2013
13RR2   01/11/15   1 x 100ml   16/04/2013
1RR   01/09/15   1 x 100ml   27/11/2012
1TT   01/02/16   1 x 100ml   27/08/2013
2RR   01/09/15   1 x 100ml   29/11/2012
2VV   01/06/16   1 x 100ml   15/10/2013
3RR   01/09/15   1 x 100ml   26/11/2012
4RR   01/09/15   1 x 100ml   03/12/2012
4VV   01/06/16   1 x 100ml   05/11/2013
5RR   01/09/15   1 x 100ml   19/12/2012
5VV   01/06/16   1 x 100ml   21/11/2013
6RR   01/09/15   1 x 100ml   18/12/2012
6VV   01/06/16   1 x 100ml   23/09/2013
7RR   01/09/15   1 x 100ml   11/01/2013
7RR2   01/09/15   1 x 100ml   10/01/2013
7VV   01/06/16   1 x 100ml   26/11/2013
8RR   01/10/15   1 x 100ml   14/02/2013
9RR   01/10/15   1 x 100ml   29/01/2013
9SS   01/02/16   1 x 100ml   30/09/2013

Tixylix Toddler Syrup 150ml

Batch number Expiry date Pack size First distributed
12SS   01/02/16   1 x 150ml   19/09/2013
14RR   01/11/15   1 x 150ml   01/03/2013

Tixylix Baby Syrup 100ml

Batch number Expiry date Pack size First distributed
10RR   01/11/15   1 x 100ml   31/01/2013
11RR   01/11/15   1 x 100ml   04/02/2013
1SS   01/11/15   1 x 100ml   05/03/2013
2SS   01/12/15   1 x 100ml   29/05/2013
2TT   01/02/16   1 x 100ml   17/10/2013
8SS2   01/01/16   1 x 100ml   01/10/2013
8VV   01/06/16   1 x 100ml   22/11/2013

Tixylix Blackcurrant Flavour Syrup 100ml

Batch number Expiry date Pack size First distributed
1VV   01/06/16   1 x 100ml   15/10/2013
3VV   01/07/16   1 x 100ml   12/09/2013
3VV2   01/06/16   1 x 100ml   07/08/2013

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Published 17 December 2014
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