Class 3 Medicines Recall: Thame Laboratories, Itraconazole 10mg/ml Oral Solution, EL (21)A/08

Thame Laboratories are recalling the above batches due to an issue with the container closure (child-resistant cap).

MDR Number MDR 219-02/21

Company name Thame Laboratories

Product description Itraconazole 10mg/ml Oral Solution PL 39307/0069

Details of affected batch

Brief description of problem

Thame Laboratories are recalling the above 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.

Advice to Healthcare Professionals

Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

Company contacts for further information

For more information or medical information queries, please contact customer.services@syrimed.co.uk

Full Recall