Download Drug alert no 9: class 2 [Acino Pharma GmbH

Primary and Community Care Directorate
Pharmacy Division
T: 0131-244 2528 F: 0131-244 2375
E: [email protected]
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IMMEDIATE MESSAGE TO:
1. Directors of Pharmacy
2. Chief Pharmacists NHS Boards
3. Hospital Pharmacy Managers
4. Medical Directors NHS Boards
5. Chief Executives NHS Boards
___
30 March 2010
Dear Healthcare Professional,
DRUG ALERT NO 9 – CLASS 2
Please find attached drug safety information from the Medicines and Healthcare products
Regulatory agency (MHRA) for onward transmission (see list below).
1. Please could all Directors of Pharmacy forward this alert to:● Community Pharmacists
● Hospital Pharmacists
● Chief Pharmacists to forward on to Medicines Information Pharmacists
2. Please could Medical Directors forward this alert to:● General Practitioners
● Hospital and Relevant Clinics
● Chief Executives of NHS Boards
Thank you for your co-operation.
Yours sincerely
IRENE FAZAKERLEY
Pharmacy Division
St Andrew’s House, Regent Road, Edinburgh EH1 3DG
www.scotland.gov.uk
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Defective Medicines Report Centre
Market Towers
1 Nine Elms Lane
London
SW8 5NQ
Telephone: +44 (0)20 7084 2574
Fax: +44 (0)20 7084 2676
DRUG ALERT
CLASS 2 MEDICINES RECALL
Action within 48 Hours
Pharmacy and Wholesaler level recall
Date: 30 March 2010
EL (10)A/09
Our Ref: MDR 63-03/10
_________________________________________________________________________
Dear Healthcare Professional,
Recall of Clopidrogel 75 mg Tablets by Marketing Authorisation
Holder – Acino Pharma GmbH. Stock distributed in both
Ratiopharm UK livery and Sandoz UK livery
Clopidogrel 75mg Tablets
EU/1/09/554/003 Ratiopharm UK livery
EU/1/09/547/003 Sandoz UK livery
Acino Pharma GmbH are recalling several batches of the Clopidrogel 75 mg tablets due to
concerns about Good Manufacturing Practices at the production site for the Active
Pharmaceutical Ingredient. A list of affected batches is attached as Appendix 1.
Stock from the marketing authorisation holder Acino Pharma GmbH has been distributed
in Ratiopharm UK livery and Sandoz UK livery. Two different marketing authorisation
numbers are used and are quoted above.
For Ratiopharm UK Ltd medical information enquiries please contact 012392 313589.
For Sandoz UK Ltd medical information enquiries please call 01276 698020.
Contd/…..
MHRA Distribution:
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)
Page 1 of 3
Date: 30 March 2010
EL (10)A/09
Our Ref: MDR 63-03/10
Remaining stocks of the above batches should be returned to the original wholesaler for
credit. For further stock enquiries please contact Ratiopharm UK Ltd on 02392 313585
or Sandoz Customer Services on 01276 698020.
Recipients of this Drug Alert are requested to bring it to the attention of relevant
professionals by copy of this letter. Primary Care Trusts are asked to forward this
document to hospitals and relevant clinics.
Yours faithfully
Ian Holloway
DMRC Manager
Page 2 of 3
Date: 30 March 2010
EL (10)A/09
Our Ref: MDR 63-03/10
Appendix 1
Ratiopharm UK Livery
Pack Size
Batch Number
Expiry Date
First Distributed
30 tablets
J25220
30.06.2012
14/10/2009
30 tablets
J25241
30.07.2012
6/11/2009
Pack Size
Batch Number
Expiry Date
First Distributed
30 tablets
9A0342
08/2012
26/11/2009
30 tablets
9A0343
08/2012
13/10/2009
30 tablets
9A0344
08/2012
15/10/2009
30 tablets
9A0345
08/2012
30/10/2009
30 tablets
9A0349
08/2012
20/01/2010
30 tablets
9A0350
08/2012
11/02/2010
30 tablets
9A0351
08/2012
13/10/2009
30 tablets
9D0355
10/2012
17/03/2010
30 tablets
9D0356
10/2012
23/03/2010
30 tablets
9D0357
10/2012
16/03/2010
30 tablets
9Y0326
10/2012
18/03/2010
30 tablets
9Y0327
10/2012
11/03/2010
Sandoz UK Livery
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