Medicine recalls
|
| |
| The United Kingdom: Class 3 Medicines Recall: Advanz Pharma, Carbimazole 10mg and 15mg Tablets |
| |
Medicines and Healthcare products Regulatory Agency (MHRA) announces that Advanz Pharma is recalling the following batches of carbimazole tablets as a precautionary measure, due to an out of specification observation for tablet appearance of samples during routine stability testing. The affected products are:
- Carbimazole 10mg Tablets (batch number: 120963, 121025)
- Carbimazole 15mg Tablets (batch number: 120967, 121028)
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.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-3-medicines-recall-advanz-pharma-carbimazole-10mg-and-15mg-tablets-el-21-a-slash-13
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Friday, May 21, 2021
Issued at HKT 15:00
|
| |
