Class 2 Drug Alert (Action within 48 hours): Greystone Ltd - Amlodipine 5mg and 10mg Tablets - EL (09)A/16

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Dear Healthcare Professional,

5mg Tablets
Batch Number	Expiry Date	Pack Size	First Distributed
T7A010707	06/2010	28	28/08/2007
T7A020707	06/2010	28	29/08/2007
T7A030707	06/2010	28	29/08/2007
T7A010208	01/2011	28	08/04/2008
T7A020208	01/2011	28	08/04/2008
T7A030208	01/2011	28	08/04/2008

 

10mg Tablets
Batch Number	Expiry Date	Pack Size	First Distributed
T8A010707	06/2010	28	03/09/2007
T8A020707	06/2010	28	03/09/2007
T8A030707	06/2010	28	03/09/2007
T8A010208	01/2011	28	08/04/2008

Greystone Ltd are recalling the above products due to serious 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 any Medical Information enquiries related to this case please call Greystone Ltd on 07941 197095 or 020 8904 9059.

For enquiries related to stock returns and credit please call Greystone Ltd on 07941 197095 or 020 8904 9059.

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

Yours faithfully

Ian Holloway
MHRA DMRC Manager

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)