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“Deficient” medicines recalled by regulator

21 October 2013

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Five prescription-only medicines have been recalled by the Medicines and Healthcare products Regulatory Agency (MRHA). 

The MRHA identified “manufacturing deficiencies” when inspecting a Wockhardt Ltd factory in India and the company has asked for the items to be returned. 

Most of the medicines are used for pain relief, but one (Gliclazide) is used for the treatment of type 2 diabetes. 

Pharmacies, clinics and retailers should return all unexpired stock for batches starting with the letter “L”. 

The items should be quarantined and returned to the original supplier for credit. 

The medicines are: 

 – Amiloride HCl 5mg Tablets

 – Clarithromycin 250mg Tablets

 – Clarithromycin 500mg Tablets

 – Gliclazide 80mg Tablets

 – Quinine Sulphate 300mg Tablets

 – Tamsulosin Pinexel 400mcg Capsules

However, a patient-level recall is not needed according to the MRHA, because although the medicines have not been manufactured to Good Manufacturing Practice standards, there is “no evidence of a patient safety risk”. 

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 medicines are available from alternative manufacturers. 

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.

“We are working with the Department of Health to ensure that people have access to the medicines they need.”