Medicines and Healthcare Products Manufactured in an Indian Factory Have Been Recalled

Medicines and Healthcare Products Manufactured in an Indian Factory Have Been Recalled

The Medicines and Healthcare Products Regulatory Agency (MHRA) are recalling five drugs made at an Indian factory because “manufacturing deficiencies” have been discovered.
The MHRA want wholesalers and chemists to return the Wockhardt Limited medicines which are used for type 2 diabetes and pain relief.
The MHRA want patients to know that there is no risk and patients should continue taking their medication as prescribed.
The decision of the agency comes after a precautionary recall from retail outlets by the manufacturer.
The manufacturing process problems were discovered during an inspection of Wockhardt’s manufacturing site in Chikalthana India in July.
The problems were poor record keeping in regards to the production and testing of the medicines manufactured at the site and the inadequate validation and production control procedures for medicines.
The MHRA said it was working to resolve these issues with Wockhardt and other international regulators.
The medicines affected by the recall are in most cases available from alternative manufacturers.
Ten prescription only medicines can still be manufactured at the Chikalthana site and used in the UK.
The MHRA has said that despite the concerns over the continuity of supply the benefits outweighed the risks to those patients still taking these medicines.
It said that patients were not required to return the medicines that they had as there was no evidence that the medicines were defective or hazardous to patients.
However the MHRA said it had to “act in the interests of public health as poor manufacturing standards means that the quality of medicines is not guaranteed”.
The recalled drugs are:
Amiloride HCI 5mg tablets
Clarithromycin 250mg tablets
Clarithromycin 500mg tablets
Gliclazide 80mg Tablets
Quinine Sulphate 300mg tablets
Tamsulosin Pinexel 400mcg tablets

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