Class 3 Medicines Recall Carbimazole 10mg and 15mg tablets (Advanz Pharma)

Class 3 Medicines Recall Carbimazole 10mg and 15mg tablets (Advanz Pharma)

May 20, 2021

Class 3 Medicines recall: Carbimazole 10mg and 15mg tablets (Advanz Pharma) 

Drug alert number: EL (21) A/13

Date issued: 20th May 2021

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 3 medicines recall for:

Carbimazole 10mg and 15mg tablets (Advanz Pharma) PL 20072/0244 and PL 20072/0245

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

Carbimazole 10mg tablets

Batch Number Expiry Date Pack Size First Distributed
120963 September 2021 1 x 100 20th May 2020
121025 September 2021 1 x 100 19th January 2021

Carbimazole 15mg tablets

Batch Number Expiry Date Pack Size First Distributed
120967 September 2021 1 x 100 26th June 2020
121028 September 2021 1 x 100 27th May 2020

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 08700 703033 or email: medicalinformation@advanzpharma.com

 



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