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: 293721
- Expiry date: Jan 2021
- Pack size: 1x28
- First distributed: 13 Jun 2018
- Batch number: 293820
- Expiry date: Jan 2021
- Pack size: 1x28
- First distributed: 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 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: [email protected]
For medical information enquiries contact
Telephone: 0800 028 5122
Email: [email protected]
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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