29.07.2020

Class 2 Medicines Recall: Kyowa Kirin Limited, Abstral 200 microgram sublingual tablets, EL (20)A/34

Threat

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.

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Source of the alert

MHRA

The risk concerns products

Product description

Abstral 200 microgram sublingual tablets

Active pharmaceutical ingredient: Fentanyl citrate

Recommendations for consumers
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

For Medical information enquiries please contact:

For Quality information please contact: Martin Smith (Responsible Person)

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.


Alert details

Country for notification

United Kingdom

Category

Pharmaceuticals

Country of origin

-

Source of the alert

MHRA - Medicines & Healthcare products Regulatory Agency, www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

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