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The Medicines and Health products Regulatory Agency (MHRA) has recalled Carbimazole 10mg and 15mg tablets of Advanz Pharma with PL 20072/0244 and PL 20072/0245.

Advanz Pharma is recalling the two 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 said.

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

 

Community pharmacy teams have been advised to stop supplying the two batches listed above immediately and return it to their supplier using supplier’s approved process.

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