Class 4 defect information: Olmetec 20mg Film Coated Tablets (MDR 12-08/18)

Daiichi Sankyo UK Limited has informed us that there is an error on the blister foil of specific batches of Olmetec 20mg Film-Coated Tablets

Product information

MDR number

MDR 12-08/18

Company name

Daiichi Sankyo UK Limited

Product description

Olmetec 20mg Film-Coated Tablets Olmesartan Medoxomil

PL number

PL 08265/0016

Batch number Expiry date Pack size First distributed
293721 Jan 2021 1x28 13 Jun 2018
293820 Jan 2021 1x28 n/a

Brief description of the problem

Daiichi Sankyo UK Limited has informed us that there is an error on the blister foil of the above batches of Olmetec 20mg Film-Coated Tablets. See picture of pack of Olmetec 20mg Film Coated Tablets with error circled as an example.

An additional ingredient, Hydrochlorothiazide, is listed under the product name. The wording on the carton and in the Patient Information Leaflet is correct and the tablets in the foils are confirmed to be Olmetec 20mg Film-Coated tablets.

To ensure continuity of supply, affected stock is not being recalled. Distribution of the above batches will cease once unaffected stock is available, however. It is anticipated that new batches will be available during week commencing 24 September 2018.

Company contact information

For general enquiries: Telephone: 01753 893600 Email: info@daiichi-sankyo.co.uk

For medical information enquiries contact Telephone: 0800 028 5122 Email: medinfo@daiichi-sankyo.co.uk

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this alert. NHS Regional teams are asked to forward this to community pharmacists, relevant clinics and dispensing general practitioners. It is not necessary to forward this notice to non-dispensing GPs.

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Olmetec 20mg Film Coated Tablets

Published 3 September 2018