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)

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.ÌýThe 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 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 Ìý 01/08/15 Ìý 1 x 100ml Ìý 26/02/2013
1TT Ìý 01/05/16 Ìý 1 x 100ml Ìý 25/11/2013
2RR Ìý 01/08/15 Ìý 1 x 100ml Ìý 26/02/2013

Tixylix Toddler Syrup 100ml

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

Tixylix Toddler Syrup 150ml

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

Tixylix Baby Syrup 100ml

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

Tixylix Blackcurrant Flavour Syrup 100ml

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

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Updates to this page

Published 17 December 2014