Thame Laboratories, Itraconazole 10mg/ml Oral Solution
- The problem
- Thame Laboratories are recalling the above batches due to an issue with the container closure (child-resistant cap).
- What to do
- Check the batch number on your pack against the list below. Do not stop taking a prescribed medicine without talking to your pharmacist, GP or prescriber first – they can check your supply and swap it if needed.
PL Number(s)
PL 39307/0069
MDR Number
MDR 219-02/21
Company Name
Thame Laboratories
Product description
Itraconazole 10mg/ml Oral Solution
- Batch number: L465
- Expiry date: 03/2022
- Pack size: 150 ml
- First distributed: 25 Jan 2021
- Batch number: L475
- Expiry date: 03/2022
- Pack size: 150 ml
- First distributed: 25 Jan 2021
Active Pharmaceutical Ingredients: Itraconazole
Brief description of the 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 for healthcare professionals
Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Further Information
For more information or medical information queries, please contact customer.services@syrimed.co.uk
Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice.
NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
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Class 3 Medicines Recall: Thame Laboratories, Itraconazole 10mg/ml Oral Solution, EL (21)A/08
Updated 15 March 2021. This page summarises an official notice. Details can change – always follow the official notice.