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

By 29th March 2021 Other No Comments

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

 

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.