Orgaran 750 anti-Xa units solution for injection – incorrect patient information leaflet
(Merck Sharp & Dohme Limited trading as Organon Laboratories Limited) Technical portion of leaflet aimed at the healthcare professional omitted. (EL (12)A/35)
28 November 2012
Class 4 medicines defect information
Caution in use
Distribute to hospital pharmacy level
MDR 29-11/12
Product details
Organon Laboratories Limited
Orgaran 750 anti-Xa units, solution for injection
(Danaparoid sodium)
PL 00065/0125
Alert details
| 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 healthcare 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 SPC for the product and healthcare professionals needing full instructions for use are referred to the Electronic Medicines Compendium (eMC) where they can access the latest SPC 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.
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)