Class 2 Drug Alert (Action within 48 hours): Strandhaven Limited - Amlodipine 5mg and 10mg Tablets - EL (09)A/21 Rev1

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Dear Healthcare Professional,

Please replace the Drug Alert issued on 1st July with this revised document. Strandhaven Limited have now informed us that the affected products are presented in Somex Pharma livery.

Products in Somex Pharma livery

5mg Tablets
Batch Number	Expiry Date	Pack Size	First Distributed
T7A030806	07/2009	28	24/08/2007
T7A011007	09/2010	28	09/01/2008
T7A021007	09/2010	28	17/01/2008
T7A031007	09/2010	28	08/10/2008
T7A041007	09/2010	28	29/10/2008

 

 

10mg Tablets
Batch Number	Expiry Date	Pack Size	First Distributed
T8A030806	07/2009	28	24/08/2007
T8A011007	09/2010	28	09/01/2008
T8A021007	09/2010	28	21/12/2007
T8A031007	09/2010	28	14/10/2008
T8A041007	09/2010	28	19/11/2008

Strandhaven Limited are recalling the above products in Somex Pharma livery due to serious Good Manufacturing Practice (GMP) deficiencies found during an inspection of their contract manufacturer.

All unused stock of the above batches should be quarantined and returned for credit.

For Medical Information enquiries related to this case please call Strandhaven Limited on 0208 5909399

For enquiries related to stock returns and credit please call Strandhaven Limited on 0208 5909399

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Primary Care Trusts are requested to forward to relevant clinics, General practitioners and Community Pharmacists.

Yours faithfully
Alison Bunce
Pharmaceutical Assessor, DMRC

 

MHRA Distribution (further recipients by cascade):

Regional Contacts for NHS Trusts and Provider Units
Chief Pharmacists: England, Scotland, Wales, Northern Ireland
Prison Health Policy Unit (DH)
Chief Pharmacists: Jersey, Guernsey, Alderney, Sark, Isle of Man, Gibraltar
Special Hospitals
Healthcare Commission for distribution to Independent Health Care Establishments
Primary Care Trusts (England)