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.