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The Medicines and Health products Regulatory Agency (MHRA) has issued a drug recall for Itraconazole 10mg/ml oral solution of Thame Laboratories.

The drug manufacturer, Thame Laboratories, has recalled Itraconazole batches due to an issue with the container closure (child-resistant cap).

The marketing authorisation holder has received a number of complaints regarding the child-resistant caps which were difficult to open, and their investigation has identified an issue with the bottle capping process during the manufacture of the product.

Product details

Batch Number Expiry Date Pack Size First Distributed
L465 03/2022 150ml 25 Jan 2021
L475 03/2022 150ml 25 Jan 2021

 

Community pharmacists have been advised to stop supplying all impacted batches immediately and quarantine remaining stock to return it to the concerned supplier using supplier’s approved process.

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