Class 3 Medicines Recall: Advanz Pharma, Carbimazole 10mg and 15mg tablets, EL (21)A/13
Advanz Pharma is recalling batches of carbimazole tablets due to an out of specification observation for tablet appearance of samples during routine stability testing.
MDR Number MDR 359-04/21
Company name Advanz Pharma
Product description
Carbimazole 10mg Tablets PL 20072/0244
Details of affected batches
|
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
Details of affected batches
|
Batch number |
Expiry date |
Pack size |
First distributed |
|
120967 |
September 21 |
1 x100 |
26 June 2020 |
|
121028 |
September 21 |
1 x100 |
27 May 2020 |
Brief description of 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 to Healthcare Professionals
Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Company contacts for further information
For more information or medical information queries please contact +44 (0) 8700 70 30 33 , or email medicalinformation@advanzpharma.com.