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Class 2 Medicines Recall (action within 48 hours): Tixylix® liquid medicines - Novartis Consumer Health UK Ltd (EL (13)A/30)

Document details:

Type: Drug Alert
Series No: EL (13)A/30
Audience: Healthcare professionals
Published: 13 December 2013
Format: Electronic
Size: A4
Pages: 3
Price:
ISBN/ISSN:
Author:
Copyright: Crown
   

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DRUG ALERT

CLASS 2 MEDICINES RECALL

Action within 48 hours


Patient level recall

13 December 2013 EL (13)A/30 Our ref: 

MDR 47-11/13


Dear Healthcare Professional,

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)

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.

Yours faithfully

Adam Burgess

Defective Medicines Report Centre
151 Buckingham Palace Road
London
SW1W 9SZ
Telephone +44 (0)20 3080 6574

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

MHRA Distribution (further recipients by cascade): N/A
Page last modified: 13 December 2013