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UK regulator recalls Generic Drugs made by India's Wockhardt Pharmaceuticals

Britain's pharmaceutical regulator has recalled a number of generic drugs made by an Indian firm after inspector's found problems with the drugs' manufacturing process.

The Medicines and Healthcare products Regulatory Agency (MHRA) stressed there was no risk to patients as it issued an alert over five of the drugs.

It is asking pharmacies, dispensing clinics and wholesalers to return five prescription-only medicines in a variety of strengths made by Mumbai-headquartered Wockhardt Pharmaceuticals.

A further five over-the-counter painkillers are being recalled by the Indian manufacturer after UK and US inspectors found problems relating to temperature controls and record keeping at the company's main manufacturing facility in Chikalthana in Maharashtra state.

The MHRA said patients should continue taking any of the medicines they had at home as prescribed.

One of the prescription-only drugs is gliclazide, a tablet used to control blood sugar in people with type 2 diabetes.

Some 467,000 NHS prescriptions are dispensed per month for this drug but not all tablets are made by the Indian manufacturer.

The over-the-counter drugs include Max Strength Cold & Flu Relief for Superdrug and Superdrug Ibuprofen. The MHRA said affected medicines were, in most cases, available from alternative manufacturers. Ten other prescription-only medicines will continue to be produced at the plant for the UK market, it said.

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 it's 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."

Health minister, Lord Howe, said: "Patients have not been put at risk by the recall of these drugs and should continue to take their medicines.

"Alternative suppliers are available for the medicines affected. We will work closely with the companies concerned to help make sure that patients can get their medicines when they need them."

The prescription-only medicines are:

Amiloride HCl 5mg tablets
Clarithromycin 250mg tablets
Clarithromycin 500mg tablets
Gliclazide 80mg tablets
Quinine Sulphate 300mg tablets
Tamsulosin Pinexel 400mcg tablets

The over-the-counter medicines are:
Aspirin 300mg tablets, Wockhardt & Co-op
Extra Pain Control Caplets, Co-op
Ibuprofen 200mg caplets, Superdrug
Max Strength Cold & Flu Relief, Superdrug
Paracetamol Extra Strength Tablets, made for firms including Happy Shopper and Spar

- Agencies (edited by Viji Alles)

Britain's pharmaceutical regulator has recalled a number of generic drugs made by an Indian firm after inspector's found problems with the drugs' manufacturing process.

The Medicines and Healthcare products Regulatory Agency (MHRA) stressed there was no risk to patients as it issued an alert over five of the drugs.

It is asking pharmacies, dispensing clinics and wholesalers to return five prescription-only medicines in a variety of strengths made by Mumbai-headquartered Wockhardt Pharmaceuticals.

A further five over-the-counter painkillers are being recalled by the Indian manufacturer after UK and US inspectors found problems relating to temperature controls and record keeping at the company's main manufacturing facility in Chikalthana in Maharashtra state.

The MHRA said patients should continue taking any of the medicines they had at home as prescribed.

One of the prescription-only drugs is gliclazide, a tablet used to control blood sugar in people with type 2 diabetes.

Some 467,000 NHS prescriptions are dispensed per month for this drug but not all tablets are made by the Indian manufacturer.

The over-the-counter drugs include Max Strength Cold & Flu Relief for Superdrug and Superdrug Ibuprofen.

The MHRA said affected medicines were, in most cases, available from alternative manufacturers. Ten other prescription-only medicines will continue to be produced at the plant for the UK market, it said.

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 it's 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."

Health minister, Lord Howe, said: "Patients have not been put at risk by the recall of these drugs and should continue to take their medicines.

"Alternative suppliers are available for the medicines affected. We will work closely with the companies concerned to help make sure that patients can get their medicines when they need them."

The prescription-only medicines are:

Amiloride HCl 5mg tablets

Clarithromycin 250mg tablets

Clarithromycin 500mg tablets

Gliclazide 80mg tablets

Quinine Sulphate 300mg tablets

Tamsulosin Pinexel 400mcg tablets

The over-the-counter medicines are:

Aspirin 300mg tablets, Wockhardt & Co-op

Extra Pain Control Caplets, Co-op

Ibuprofen 200mg caplets, Superdrug

Max Strength Cold & Flu Relief, Superdrug

Paracetamol Extra Strength Tablets, made for firms including Happy Shopper and Spar