MHRA Class 3 Medicines Recall: Itraconazole 10mg/ml oral solution (Thame Laboratories)

MHRA Class 3 Medicines Recall: Itraconazole 10mg/ml oral solution (Thame Laboratories)

March 15, 2021

Class 3 Medicines recall: Itraconazole 10mg/ml oral solution (Thame Laboratories)

Drug alert number: EL (21) A/08

Date issued: 15th March 2021

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 3 medicines recall for:

Itraconazole 10mg/ml oral solution (Thame Laboratories) PL 39307/0069

Thame Laboratories are recalling the below 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.

 

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

Advice for healthcare professionals

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

Full drug alert can be viewed here.

Company contacts for further information

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

 

 



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