Class 2 Medicines Recall: Kyowa Kirin Limited, Abstral 200 microgram sublingual tablets, EL (20)A/54
Kyowa Kirin Limited is recalling specific batches as a precautionary measure, due to the reports of double tablets in a single blister pocket.
PL Number
PL 16508/0031
MDR Number
MDR 091-11/20
Company Name
Kyowa Kirin Limited
Product description
Abstral 200 microgram sublingual tablets
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 608973601 | 30 September 2021 | 10 | 9 February 2020 |
| 608973602 | 30 September 2021 | 30 | 28 June 2020 |
Active pharmaceutical ingredient: Fentanyl citrate
Brief description of the problem
Kyowa Kirin Limited is recalling the above 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 batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Further Information
For Stock control enquiries please contact: Karen Murray, Commercial Manager
- Telephone: +44 (0) 7712 001288
- E-mail: [email protected]
For Medical information enquiries please contact:
- Medical Information Direct Line: + 44 (0)1896 664 000
- E-mail: [email protected]
For Quality information please contact: Martin Smith (Responsible Person)
- Telephone: +44 7904671807
- E-mail: [email protected]
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this notice.
NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
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