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Medicines Recall Alert: Class 3 Medicines Recall: Advanz Pharma, Carbimazole 10mg and 15mg tablets, EL (21)A/13

Published On:

28 May 2021

Published In:

Advanz Pharma is recalling batches of carbimazole tablets due to an out of specification observation for tablet appearance of samples during routine stability testing.

PL Number(s)

PL 20072/0244

PL 20072/0245

MDR Number

MDR 359-04/21

Company Name

Advanz Pharma

Product description

Carbimazole 10mg Tablets PL 20072/0244

Batch number Expiry date Pack size First distributed
120963 September 21 1 x100 20 May 2020
121025 September 21 1 x100 19 January 2021

Carbimazole 15mg Tablets PL 20072/0245

Batch number Expiry date Pack size First distributed
120967 September 21 1 x100 26 June 2020
121028 September 21 1 x100 27 May 2020

Active Pharmaceutical Ingredients: carbimazole

Brief description of the problem

Advanz Pharma is recalling the above 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.

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 +44 (0) 8700 70 30 33 , or email [email protected].

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.

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Class 3 Medicines Recall: Advanz Pharma, Carbimazole 10mg and 15mg tablets, EL (21)A/13

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