Class 2 MHRA medicines recall – Abstral 200microgram sublingual tablets (Kyowa Kirin Limited) PL 16508/0031 

Drug alert number: EL (20)A/54

Date issued: 25 November 2020

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 2 medicines recall for:

Abstral 200microgram sublingual tablets (Kyowa Kirin Limited) PL 16508/0031

Kyowa Kirin Limited is recalling the below batches as a precautionary measure, due to the reports of double tablets in a single blister pocket. 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.

Advice for healthcare professionals

• Stop supplying the above products immediately and remove from the shelves within your pharmacy/store. Quarantine all remaining stock and return these to your supplier using your supplier’s approved process.

Further information

Full drug alert can be viewed here.

Company contacts for further information

For stock control queries please contact:

Karen Murray, Commercial Manager
Telephone: Mobile: +44 (0) 7712 001288
E-mail: karen.murray@kyowakirin.com

For any medical information enquires please contact:

Medical Information Direct Line: + 44 (0)1896 664 000
E-mail: medinfo@kyowakirin.com