Class 2 Drug Alert (Action within 48 hours): Ferring Pharmaceuticals Ltd - Zomacton 10 mg powder for reconstitution with diluent, Somatropin (rbe)

---

Dear Healthcare Professional,

Batch number	Expiry date	Pack size	First distributed
CD0382G	Jun-11	1 vial and 1 diluent syringe	13/01/2010
CD0552D	Aug-11	1 vial and 1 diluent syringe	12/05/2010
CD0552G	Nov-11	1 vial and 1 diluent syringe	30/03/2010
CD0640A	Nov-11	1 vial and 1 diluent syringe	18/04/2010
CD0640E	Nov-11	1 vial and 1 diluent syringe	15/06/2010
CD0640K	Nov-11	1 vial and 1 diluent syringe	09/07/2010
CE0192B	Feb-12	1 vial and 1 diluent syringe	30/07/2010
CE0327E	Jun-12	1 vial and 1 diluent syringe	11/11/2010
CE0327G	May-11	1 vial and 1 diluent syringe	18/10/2010
CE0481C	Jun-12	1 vial and 1 diluent syringe	17/12/2010

Ferring Pharmaceuticals Ltd is recalling all remaining stock of the above batches to wholesaler, pharmacy and clinic level. The preservative levels in a small number of the prefilled diluent syringes are below specification but remain at levels not expected to pose a significant patient risk. The problem is estimated to affect less than 0.6% of the syringes.

For medical information enquiries please call Ferring Pharmaceuticals Ltd on 08449 310054.

All unused stock of these batches should be quarantined and should be held in refrigerated condition (2°C to 8°C). Please wait for instructions from the original supplier with regard to returning stock for credit. For enquiries relating to stock returns please call Ferring Pharmaceuticals Ltd on 08449 310052.

Recipients of this Drug Alert are requested to bring it to the attention of relevant professionals by copy of this letter. Primary care trusts are asked to forward this information to general practitioners, community pharmacists and relevant clinics.

Yours faithfully

Ian Holloway
MHRA DMRC Manager

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)