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DRUG ALERT
Class 4 medicines defect informationFor distribution to community and hospital pharmacists
| 11 December 2008 | EL (08)A/20 | Our ref: MDR 70-11/08 |
Dear Healthcare Professional,
Merck Serono UK
Gonal-F 900 IU/1.5ml solution for injection in a pre-filled pen
(follitropin alfa, recombinant human follicle stimulating hormone)
|
Batch Number
|
Expiry Date
|
Pack Size
|
First Distributed
|
|
Y10B0063
|
03/2010
|
1
|
06/06/2008
|
|
Y10B2052
|
03/2010
|
1
|
25/07/2008
|
|
Y10B4293
|
04/2010
|
1
|
18/08/2008
|
|
Y10B7228
|
04/2010
|
1
|
12/09/2008
|
|
Y10B8889
|
04/2010
|
1
|
17/10/2008
|
|
Y11B2580
|
05/2010
|
1
|
31/10/2008
|
|
Y11B3841
|
06/2010
|
1
|
11/11/2008
|
The MHRA has been informed that there is an error in the title of the package leaflet for some batches of Gonal-F 900 IU/1.5ml solution for injection in pre-filled pens. Details of the affected batches are shown above.
The actual concentration of Gonal-F in the pre-filled pen device is 900 IU/1.5ml and this is correctly stated on both the label of the pen injection device and the external packaging. It is also stated correctly in the body of the text of the package leaflet in section 6. However the title of the package leaflet indicates a concentration of 900 IU/0.5ml.
The error in the package leaflet should not affect the dosage of Gonal-F administered to the patient as the package leaflet clearly specifies that the dose on the pen should be set in IU and not by volume.
We have been asked to advise pharmacists that this information should be relayed to patients when dispensing, and should be conveyed to all pharmacists working within their pharmacy.
To avoid stock disruption, distribution of affected stock will continue, therefore further deliveries over the next few months will display this error. Corrected package leaflets are being produced but it is unlikely that these will be supplied to the market before January 2009.
Further Information
For further enquiries, please telephone Merck Serono Medical Information on 0208 818 7373.
Primary Care Trusts are asked to bring this information to the attention of Community Pharmacists and other concerned Health Professionals by copy of this letter.
Yours faithfully
Alison Bunce
Pharmaceutical Assessor
DMRC
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)
Class 4 Drug Alert (Caution in use): Merck Serono UK - Gonal-F 900 IU/1.5ml solution for injection in a pre-filled pen - EL (08)A/20 
