Regulator warns of recall of Tixylix cough medicine

Monday December 16 2013

“Parents urged to check children's medicines after plastic contaminated some batches,” the Daily Mirror has reported.

Several similar headlines in The Independent and on BBC News have highlighted a product recall for Tixylix cough syrup, which is available over the counter at pharmacies.

Some bottles of the product may contain pieces of plastic due to a fault with the tamper seal. Tixylix maker Novartis Consumer Health has informed the UK drug regulator, the MHRA, of the problem.

Adam Burgess, head of the Defective Medicines Reporting Centre at the MHRA told the media: “This is a precautionary recall and there is currently no evidence that people have had any problems with these medicines.

“If people have bought Tixylix we ask that they check the batch number on the bottle label next to the expiry date to see if it is one of the batches being recalled. If anyone has an affected batch they should return it to the place of purchase for a refund.”

Separately, Boots Pharmaceuticals has issued a recall for all batches of a range of of paracetamol, gripe mixture and cough and cold medicines because of a similar manufacturing problem.

What is Tixylix?

Tixylix is a brand of cough medicine in a liquid form. It is marketed in different varieties for babies or toddlers.

The specific indications vary according to the particular medicine.

The preparations that are currently being recalled by the manufacturer are:

  • Tixylix Baby Syrup 100ml
  • Tixylix Blackcurrent Flavour Syrup 100ml
  • Tixylix Chesty Cough 100ml
  • Tixylix Toddler Syrup 100ml or 150ml

The MHRA website lists all the potentially affected Tixylix batches and all the recalled Boots medicines.

What is the problem with these cough medicines?

Novartis Consumer Health has been alerted to a potential manufacturing fault with the “tamper seal” on the products. This may have resulted in small pieces of plastic getting into the liquid medicines.

This potential defect is only said to affect the above batches of Tixylix manufactured after October 2012 and with an expiry date ranging from 01/08/15 to 01/06/16. The current recall is a precautionary measure only: so far no defective products have been found, and no reported adverse events.

Boots Pharmaceuticals is aware of a similar problem, has advised a precautionary recall and has had no reports of adverse events.

What does the MHRA advise parents concerned about these cough medicines?

The Medicines and Healthcare Products Regulatory Agency (MHRA), the body that regulates the safety of medicines and medical products in the UK, generally recommends that over-the-counter cough and cold medicines shouldn't be given to children under the age of six.

The MHRA recommended at the end of last week that pharmacists and retailers quarantine all unexpired stock of the Tixylix products listed above, and return it to their original supplier for credit.

Separately, the MHRA also issued a notification that Boots Pharmaceuticals has chosen to extend the scope of the original recall to include further batches (all batches in shelf life, regardless of production and expiration dates) and further medicines that could be potentially impacted by the fault.

The medicines Boots has recalled include:

  • Boots Pharmaceuticals Chesty Cough Relief 100mg/5ml Oral Solution
  • Boots Pharmaceuticals Dry Cough Relief Oral Solution
  • Boots Pharmaceuticals Mucus Cough Relief 100mg/5ml Oral Solution
  • Boots Pharmaceuticals Paracetamol 6 years Plus 250mg/5ml Oral Solution 200ml
  • Boots Pharmaceuticals Paracetamol 6 Years Plus 250mg/5ml Suspension 100ml
  • Boots Pharmaceuticals Ibuprofen 3 Months Plus 100mg/5ml Oral Suspension Strawberry Flavour
  • Boots Pharmaceuticals Tickly Cough Relief Oral Solution
  • Boots Pharmaceuticals Paracetamol 3 Months Plus 120mg/5ml Suspension 100ml
  • Boots Pharmaceuticals Paracetamol 3 Months Plus 120mg/5ml Suspension 200ml
  • Boots Pharmaceuticals Cough Syrup 3 Months Plus
  • Boots Pharmaceuticals Gripe Mixture 1 Month Plus
  • Almus Paracetamol 250mg/5ml Oral Suspension
  • Almus Ibuprofen 3 Months plus 100mg/5ml Oral Suspension Strawberry Flavour

Analysis by Bazian
Edited by NHS Choices