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Class 2 Drug Alert (Action within 48 hours) : Sandoz Limited - Multiple Product Drug Alert - Baclofen 10mg Tablets; Fluoxetine 20mg Capsules and Metformin 500mg and 850mg Tablets - EL (09)A/20

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Document details:

Type: Drug Alert
Series No: EL (09)A/20
Audience: Healthcare Professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 2
Price: Free
ISBN/ISSN: n/a
Author:
Copyright: Crown
   

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DRUG ALERT

CLASS 2 MEDICINES RECALL
Action Within 48 Hours
PHARMACY AND WHOLESALER LEVEL RECALL
01 July 2009 EL (09)A/20 Our ref:  MDR 59-06/09

Dear Healthcare Professional,

Sandoz Limited

Multiple Product Drug Alert

Product Pack Size PL Number
Baclofen 10mg Tablets 84 04416/0160
Fluoxetine 20mg Capsules 30 04416/0330
Metformin 500mg Tablets 28 04416/0300
Metformin 850mg Tablets 56 04416/0301


Sandoz Limited are recalling the above products due to serious Good Manufacturing Practice (GMP) deficiencies found during an inspection of one of their contract manufacturers.

All unexpired stock of these products should be quarantined and returned for credit.

For any Medical Information enquiries related to this case please call Sandoz Limited Medical Information on 01420 478301.

For enquiries related to stock returns and credit please call Sandoz Limited Customer Service on 01420 478301 or email sales.sandoz-gb@sandoz.com

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 this 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)
Page last modified: 02 July 2009