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CLASS 3 RECALL - CARBIMAZOLE TAB 10MG & 15MG

Recalls and Alerts

Class 3 Recall

CLASS 3 RECALL - CARBIMAZOLE TAB 10MG & 15MG

Advanz Pharma is recalling the below batches of Carbimazole tablets as a precautionary measure, due to an out of specification observation for tablet appearance of samples during routine stability testing. Based on the investigation performed, the observed defect was related to oxidation of the excipient red iron oxide on the surface of the tablets, due to a lack of proper mixing during the manufacturing process. There is no safety or efficacy issues as a result of this observation.

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-intrapharm-laboratories-ltd-kolanticon-gel-500ml-el-21-a-slash-01?utm_medium=email&utm_campaign=govuk-notifications&utm_source=1c3cadd1-c259-4e77-b3e8-c13faf584fe2&utm_content=immediately  

Pip code

Product description

Supplier

Batch Numbers

8127730

CARBIMAZOLE TAB 10MG

ADVANZ PHARMA

120963

121025

1233931

CARBIMAZOLE TAB 10MG

ADVANZ PHARMA

120963

121025

8127938

CARBIMAZOLE TAB 15MG

ADVANZ PHARMA

120967

121028

Further Information

 

For more information or medical information queries please contact +44 (0) 8700 70 30 33 , or email medicalinformation@advanzpharma.com.

 

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

 

If you have any questions, then please contact your local Service Centre Customer Services team.