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Class 4 Drug Alert (Caution in Use): Orgaran 750 anti-Xa units, solution for injection - Danaparoid sodium - Organon Laboratories Limited - EL (12)A/35

Document details:

Type: Drug Alert
Series No: EL (12)A/35
Audience: Healthcare professionals
Published:
Format: Electronic
Size: A4
Pages: 2
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

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DRUG ALERT

CLASS 4 MEDICINES DEFECT INFORMATION

Caution in Use


Distribute to Hospital Pharmacy Level

28 November 2012 EL (12)A/35 Our ref: 

MDR 29-11/12


Dear Healthcare Professional,

Organon Laboratories Limited

Orgaran 750 anti-Xa units, solution for injection

(Danaparoid sodium)

PL 00065/0125


Batch Number

Expiry Date

Pack Size

First Distributed

166413001

December 2014

10 ampoules

14 February 2012

222239001

January 2015

10 ampoules

1 March 2012

22224001

January 2015

10 ampoules

10 April 2012

238587001

February 2015

10 ampoules

3 May 2012

296983001

April 2015

10 ampoules

28 June 2012

307099001

July 2015

10 ampoules

10 September 2012

335914001

August 2015

10 ampoules

8 October 2012

Merck Sharp & Dohme Limited (trading as Organon Laboratories Limited) has recently amended the package leaflet for the above product to include user tested text in the patient leaflet section.  They have informed us that during this process the previous technical portion of the leaflet aimed at the Health Care Professional administering the product has been omitted.

To ensure continuity of supply, distribution of affected stock will continue and it will be necessary to release further batches.

The Technical part of this leaflet is the same as the SmPC for the product and healthcare professionals needing full instructions for use are referred to the Electronic Medicines Compendium (eMC) (external link) where they can access the latest SmPC for Orgaran.

Merck Sharp & Dohme Limited is working to resolve this situation as quickly as possible but it may be a few months before new stock containing both patient and technical leaflets is available.

For further information, please contact Merck Sharp & Dohme Medical Information team on 01992 467272.

Recipients of this Drug Alert are requested to bring it to the attention of relevant professionals by copy of this letter.

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: 28 November 2012