Medicine recalls
|
| |
| The United Kingdom: Class 2 Medicines Recall: Kyowa Kirin Limited, Abstral 200 microgram sublingual tablets, EL (20)A／54 |
| |
The Medicines and Healthcare products Regulatory Agency (MHRA) announces that Kyowa Kirin Limited is recalling two batches of Abstral 200 microgram sublingual tablets as a precautionary measure, due to the reports of double tablets in a single blister pocket. The active pharmaceutical ingredient of the product is fentanyl citrate. Product details are as follows:
Abstral 200 microgram sublingual tablets
Batch No.: 608973601, Expiry Date: 30 September 2021, Pack Size 10 tablets;
Batch No.: 608973602, Expiry Date: 30 September 2021, Pack Size 30 tablets
This is a follow up alert, following the issue of EL (20)A/34. Since this notification, Kyowa Kirin Limited have initiated corrective actions to resolve the issue. Complaint batches 608973601 and 608973602 were manufactured prior to the corrective actions being implemented.
One of the corrective actions involved the vision system, which has undergone re-qualification. X-ray units have been sourced to scan and inspect products for empty blister pockets and double fills. X-ray units have been used to inspect all products manufactured and are now part of the standard packing process prior to cartonning. All future blisters will be 100% checked by X-ray units prior to release to the market.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-kyowa-kirin-limited-abstral-200-microgram-sublingual-tablets-el-20-a-54
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was issued by the MHRA, and was posted on the Drug Office website on 30 Jul 2020.
Ends/ Thursday, November 26, 2020
Issued at HKT 18:00
|
| |
|
