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
Posted in: Dispensing & Supply