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Class 3 Recall Itraconazole 10mg/Ml Oral Solution 150ml

Recalls and Alerts

Class 3 Recall

17.03.2021

Class 3 Recall Itraconazole 10mg/Ml Oral Solution 150ml

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.

The affected products' details are as follows:

PIP Code

Product Description

Supplier

Affected Batch

8073249

ITRACONAZOLE 10MG/ML ORAL SOLUTION 150ML

THAME LABORATORIES

L465

L475

1216670

ITRACONAZOLE 10MG/ML ORAL SOLUTION 150ML

THAME LABORATORIES

L465

L475

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

Please return all affected stock to your original supplier for credit. Unfortunately we can only accept stock purchased from us (Alliance Healthcare Distribution Limited). Any other stock will be returned to your stores/Pharmacies.

 

This recall will remain open for 3 months from the date issued unless an alternative date is agreed by instigator. The closure of this will be 15/06/2021. Please note after this date customer returns may still be accepted but customers may not be credited.

 

Recipients of this Drug Alert should bring it to the attention of relevant contacts.

 

If you have any questions, then please contact your local service centre customer service team.