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Alert By Medicines Regulator On Potential Contamination - Seton Products Ltd Woodward's Gripe Water, UK

August 16, 2017

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a drug alert to healthcare professionals informing them of a precautionary recall of certain batch numbers of Seton Products Ltd Woodward's Gripe Water. The licence holder, Seton Products Ltd, is recalling certain batches of this gripe water product (PL 11314/0139) due to concerns with potential microbial contamination (bacteria) in the water used during manufacture at their contract manufacturer, William Ransom & Son plc, site at Witham, Essex. Companies are being asked to quarantine any remaining stock and return it to their supplier for credit.

It must be stressed that there is a very low risk that children will be affected. However if your child starts to feel unwell after taking this product, you should seek advice from your pharmacist or doctor. If you have this product at home, you should not use it and take it back to where you purchased it. There are plenty of alternative gripe water products on the UK market. No other UK products manufactured by William Ransom & Son plc and supplied to the UK market are considered to present a risk to people

Notes:

1. This issue came to light on 21 November 2007, during a routine inspection of the manufacturing plant at William Ransom & Son plc's Witham site in Essex by MHRA Good Manufacturing Practice inspectors. The inspection identified problems with the water system concerning bacterial contamination. The manufacturer's licence for the plant has been suspended by the MHRA until the problem is rectified.

2. A copy of the MHRA drug alert, including details of the relevant batch numbers, can be see on the website at the following link.

3. 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.

Medicines and Healthcare products Regulatory Agency