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Medicines Watchdog Initiates Recall of Medicines Manufactured by Wockhardt Ltd

The Medicines and Healthcare products Regulatory Agency (MHRA) on 17th October asked pharmacies, dispensing clinics and wholesalers to return five different prescription-only medicines in a variety of strengths. This follows a precautionary recall made by the manufacturer, Wockhardt Ltd, who are asking retail outlets to return five over the counter medicines.

 

This action follows manufacturing deficiencies identified by the MHRA during an inspection of Wockhardt's manufacturing site in Chikalthana, India.

Most of the medicines affected by the precautionary recall are used for pain relief but it also includes one medicine used to treat Type 2 diabetes (Gliclazide).

The affected medicines are in most cases available from alternative manufacturers and the Department of Health will closely work with them to help ensure that patients can get their medicines when they need them.

Ten prescription-only medicines can continue to be made at the Chikalthana site and can still be supplied to patients in the UK. This is because, due to concerns over the continuity of supply, the benefits to patients of continuing to take these medicines outweigh the risk from any quality concerns with the medicine.

People do not need to return their medicines because there is no evidence that the medicines affected by the precautionary recall in the UK are defective. Therefore, it is important that people continue to take their medicines as prescribed.

This is not a patient level recall because although the medicines that are affected have not been manufactured to Good Manufacturing Practice (GMP) standards, there is no evidence of a patient safety risk from medicines that have been sold in the UK. However, the MHRA has to act in the interests of public health as poor manufacturing standards means that the quality of medicines is not guaranteed.

The manufacturing deficiencies identified by the MHRA during the inspection of Wockhardt's Chikalthana site in July 2013 included, poor record keeping relating to the manufacture and testing of the medicines made at the site, and inadequate validation and production controls for medicines. The MHRA is working with Wockhardt and other international regulators to resolve this.

Gerald Heddell, the MHRA's Director of Inspection, Enforcement and Standards, said:

People can be reassured that there is no evidence of a safety risk from the medicines made at Wockhardt,s Chikalthana site so its important people continue to take their medicines as prescribed.

Ten prescription-only medicines can continue to be made at the Chikalthana site and can still be supplied to patients in the UK. This is because, due to concerns over the continuity of supply, the benefits to patients of continuing to take these medicines outweigh the risk from any quality concerns with the medicine.

We are working with the Department of Health to ensure that people have access to the medicines they need. Anyone who has questions should speak to their pharmacist or GP.

The MHRA's Class 2 Drug Alert can be viewed here. This includes a list of all the medicines that are affected by the precautionary recall.

The MHRA issued a Class 2 drug alert about Wockhardt's recall of medicines from their manufacturing site in Waluj, India to pharmacies, dispensing clinics and wholesalers on 11 July 2013. Click here for the press release.

 

 

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