Novartis Consumer Health U.K. Ltd. has 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.
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.
The recall is being conducted with the knowledge of the Medicines and Healthcare Products Regulatory Agency and only affects Britain.
Release Date: December 13, 2013
Source: MHRA