Class 2 Medicines Recall: Kyowa Kirin Limited, Abstral 200 microgram sublingual tablets, EL (20)A/34
Kyowa Kirin Limited is recalling a specific batch as a precautionary measure, due to the reports of double tablets in a single blister pocket. This was identified during reference sample inspection and there is a potential low risk of accidental double dosage.
PL Number
PL 16508/0031
MDR Number
MDR 172-06/20
Company Name
Kyowa Kirin Limited
Product description
Abstral 200 microgram sublingual tablets
- Batch Number: 608777302
- Expiry Date: 31 July 2021
- Pack Size: 30
- First Distributed: 24 Dec 2019
Active pharmaceutical ingredient: Fentanyl citrate
Brief description of the problem
Kyowa Kirin Limited is recalling the above batch as a precautionary measure, due to the reports of double tablets in a single blister pocket. This was identified during reference sample inspection and there is a potential low risk of accidental double dosage.
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: Stuart Hay, Commercial Director
- Telephone: +44 (0) 1896 664045
- Mobile: +44 (0) 7968 983286
- E-mail: Stuart.Hay@kyowakirin.com
For Medical information enquiries please contact:
- Medical Information Direct Line: + 44 (0)1896 664 000
- E-mail: medinfo@kyowakirin.com
For Quality information please contact: Martin Smith (Responsible Person)
- Telephone: +44 7904671807
- E-mail: Martin.Smith@kyowakirin.com
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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