Precautionary Alert On Traces Of Contaminant In Teething Gel

Main Category: Pharmacy / Pharmacist
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 17 Dec 2009 - 2:00 PDT

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The Medicines and Healthcare products Regulatory Agency (MHRA) has today issued a precautionary drug alert on the recall of Dentinox Teething Gel 15mg.

DDD Limited, the medicine's licence holder, is carrying out the precautionary recall due to the presence of very small amounts of a contaminant, glyoxal, in the product.

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

The batch numbers being recalled are BASEP09, BBSEP09, BGSEP09, BLSEP09, BFOCT09, BFNOV09, BGNOV09 and BINOV09.

If parents or carers have the affected medicine at home, they are advised to stop using it and return it to the retailer where they purchased the product.

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

Notes

1. The affected batches are being recalled as a precaution only as it is used in infants and young children with less developed metabolic systems. This is due to the possibility of an accumulation of the contaminant occurring.

2. Glyoxal is an organic compound that occurs naturally and is found in the environment and in some foods at very low levels.

3. Consumers can return the affected product to DDD Limited or their local retailer and will be refunded in full with no receipt required. Consumers can also send their product to Customer Services, DDD Ltd, Caxton Court, Caxton Way, Watford, Herts, WD18 8RH.

4. 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.

Source
Medicines and Healthcare products Regulatory Agency

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