Medicines produced at Indian plant recalled

Drugs made for leading firms, including Superdrug, are being recalled after inspectors found problems with manufacturing at an Indian plant.

Inspectors in Britain and the US found problems with the manufacturing process. Picture: Phil Wilkinson

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

It is asking pharmacies, dispensing clinics and wholesalers to return five prescription-only medicines in a variety of strengths made by Wockhardt, based in Chikalthana, Aurangabad, in India.

A further five over-the-counter painkillers are being recalled by the Indian company after inspectors in Britain and the United States found problems with the manufacturing process.

These included concerns over temperature control and record-keeping, and led to the withdrawal of the plant’s good manufacturing practice certificate.

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 some of the retailer’s own-brand 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 that 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.”

A spokeswoman for Superdrug said: “We can confirm the MHRA has asked that we remove from sale our own brand Max Strength Hot Lemon Powders (x10) and our own-brand 200mg Ibuprofen Caplets (x16).

“No other Superdrug own-brand products are affected.

“This action has been taken as a precautionary measure after a MHRA supplier audit and we have been assured there are no safety-related issues. However, if any customers would like to return the products to our stores, we will issue a full refund.”

The drugs affected

prescription-only medicines

• Amiloride HCl 5mg tablets

• Clarithromycin 250mg tablets

• Clarithromycin 500mg tablets

• Gliclazide 80mg tablets

• Quinine Sulphate 300mg tablets

• Tamsulosin Pinexel 400mcg tablets

over-the-counter medicines

• Aspirin 300mg tablets, Wockhardt and 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