Medicine recalls
|
|
The United Kingdom: Class 3 Medicines Recall: Lynparza capsule 50mg (olaparib) |
|
The Medicines and Healthcare products Regulatory Agency (MHRA) announces that AstraZeneca is recalling batch NG327 of Lynparza capsule 50mg (olaparib) as the level of olaparib polymorphic form L exceeds the registered specification limit. As a precautionary measure, six other batches (batch numbers: NG143, NK719, NJ972, NR730, NK591 and NR497) are also being recalled as they may exceed the limit before the end of their shelf life.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-3-medicines-recall-lynparza-capsule-50mg-olaparib
In Hong Kong, Lynparza Capsules 50mg (HK-64538) is a pharmaceutical product registered by AstraZeneca Hong Kong Ltd (AstraZeneca), and is a prescription-only medicine. As confirmed with AstraZeneca, the seven affected batches mentioned in the above MHRA news have not been imported into Hong Kong. Related news on recall of three other batches of Lynparza capsule 50mg (batch numbers: NG944, NG695, NK349) by Health Canada was posted on the Drug Office website on 7 March 2018.
On 21 February 2018, the Department of Health (DH) endorsed AstraZeneca to recall 3 other batches (batch numbers: NG699, NF848, NJ141) of Lynparza Capsules 50mg in Hong Kong which were affected by the same issue. The recall of these three batches in Hong Kong has been completed.
Ends/Tuesday, March 13, 2018
Issued at HKT 16:00
|
|
|