Class 2 Alert Issued By MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 2 recall regarding Wockhardt UK’s Amoxicillin Sodium 500mg Powder, raising the level from the Class 4 alert issued earlier this month.

The recall relates to batch numbers 1WA4002, 1WA4003 and 1WA4004, each of which have an expiry date of Jan 31st 2017 and come in 10 x 500mg pack sizes.

While a Class 4 alert was issued on July 9th, the MHRA has extended the recall following reports of injection site reactions in both children and adults. The Class 4 alert is still in force on all batches for all neonates and infants (below one year old).

An investigation by Workhardt and its contract manufacturer in Italy is ongoing. The manufacturer has stated there is no evidence that the batches are defective.

Expert Opinion

It is a worry to see concerns related to this product emerge and while the manufacturer suggests there are no specific issues identified regarding the batches, it does raise questions as to why adverse symptoms have arisen. <br/> <br/>"It is vital that the MHRA and the manufacturer work to determine what can be done to ensure the expected standards of patient safety. <br/> <br/>"Through our work we see numerous examples of how people can fall ill or be injured as a result of defective medical products and it is vital that lessons are learned to ensure that all products on the market meet the standards expected by those who use them and those who are treated with them." Kevin Timms - Solicitor