Press release: Medicines regulator’s alert on low level contamination in Metatone Tonic

Press release

Date:	10 December 2009
Time:	15:45
Contact:	Press Office 020 3080 7651/3166 or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189

The Medicines and Healthcare products Regulatory Agency (MHRA) has today issued a drug alert about a batch recall of Metatone Tonic 300 ml.

Chefaro UK Ltd, the medicine’s licence holder, is carrying out the recall due to the presence of very small amounts of petrol in the medicine. The affected batch number is 112 and the product itself could smell of petrol.

There is currently no evidence of harm and no suspected adverse drug reactions have been reported.

If people have the affected medicine at home, they are advised to stop using it, return it to the retailer where they purchased the product and request it to be replaced with another Metatone Tonic from the range, or a full refund.

If people have any concerns or suspected side effects, they should seek advice from their pharmacist or doctor. They can also contact Customer Services, Ceuta Healthcare Ltd on 01202 449 752 for further medical information.

Pharmacists and wholesalers with the affected product should quarantine it and contact their original supplier.

The MHRA and Chefaro UK Ltd are liaising with the contract manufacturer to determine the cause of the contamination.

Notes to Editor

1. A copy of the MHRA drug alert can be found via the following link: Class 2 Drug Alert (Action within 48 hours): Chefaro UK Limited - Metatone - EL (09)A/33
2. Metatone Tonic is used to restore health and vitality after illness, such as colds and influenza. Metatone Tonic is a general sales list medicine, licensed for sale and normal use without supervision or advice from a pharmacy or doctor.
3. There are 22,653 bottles of Metatone Tonic in batch 112.
4. Suspected adverse reactions to medicines can be reported to the MHRA via the Yellow Card scheme
5. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone –the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.
   www.mhra.gov.uk
6. Press enquiries for Chefaro UK Ltd should be directed to Gillian Waddell or Susan Lee on 020 7498 8211.