Class 4 MHRA drug alert – Olmetec 20mg Film-Coated Tablets (Daiichi Sankyo)

Class 4 MHRA drug alert – Olmetec 20mg Film-Coated Tablets (Daiichi Sankyo)

September 3, 2018

Class 4 MHRA drug alert – Olmetec (Olmesartan Medoxomil) 20mg Film-Coated Tablets (Daiichi Sankyo)

Drug alert number: EL(18)A/14

Date issued: 3rd September 2018

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 pharmacy level caution in use for:

Olmetec (Olmesartan Medoxomil) 20mg Film-Coated Tablets (Daiichi Sankyo)

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

Batch Number Expiry Date Pack Size First Distributed
293721 01  2021 1 x 28 13 Jun 2018
293820 01  2021 1 x 28 n/a

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.

For general enquiries please contact info@daiichi-sankyo.co.uk, or by phone on 01753 893600

PL number: PL 08265/0016

To view the alert please visit the GOV.uk website.



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