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Class 2 Drug Alert (Action within 48 hours): Goldshield Pharmaceuticals - Phenindione 25 mg Tablets - EL (10)A/14

Document details:

Type: Drug Alert
Series No: EL (10)A/14
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 2
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.

DRUG ALERT

CLASS 2 MEDICINES RECALL
Action Within 48 Hours
PHARMACY LEVEL RECALL
30 June 2010 EL (10)A/14 Our ref:  MDR 91-06/10

Dear Healthcare Professional,

Goldshield Pharmaceuticals

Phenindione 25 mg Tablets

PL 10972/0038

Batch Number Expiry Date Pack Size First Distributed
68162 Feb 2012 1x28 03 Jun 2010

Goldshield Pharmaceuticals is recalling the above batch because some tablets within the batch are showing a dark orange/brown discolouration. The tablets are normally green. The cause of the discolouration is under investigation.

Since Goldshield Pharmaceuticals is the single source of this product, there may be supply issues. This is at present being addressed by the Company.

For medical information enquiries, please contact Goldshield Medical Information on 08700 703033, medicalinformation@goldshieldgroup.com

Pharmacists are asked to quarantine any remaining stock from this batch and return it to the original wholesaler. Wholesalers are asked to return stock from this batch to Movianto. For further stock return enquiries, please contact Movianto on 01234 248500. For information on availability of replacement stock, please contact Goldshield Pharmaceuticals on 0208 588 9273.

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Primary care trusts are asked 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: 22 November 2010