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DRUG ALERT
Class 4 medicines defect informationDistribute to pharmacy level
| 14 July 2009 | EL (09)A/22 | Our ref: MDR 09-07/09 |
Dear Healthcare Professional,
Solvay Healthcare Limited
Creon Micro Pancreatin 60.36mg Gastro-resistant Granules
| Batch Number | Expiry Date | Pack Size | First Distributed |
| 44697 | 11/2010 | 20g | 30 June 2009 |
Solvay Healthcare Limited has informed us that the lid on bottles of Creon Micro Pancreatin 60.36mg Gastro-resistant Granules from the above batch may spontaneously open, either fully or partially. The product is only affected once the tamper evident strip has been removed.
To avoid stock disruption, this batch is not being recalled. Solvay Healthcare Limited hope to have a new batch available during week commencing 03 August 2009. In the meantime, please inform recipients of this batch of the issue, including those patients who may already have received it.
Patients/carers are advised to tape the lid securely shut once the tamper evident strip is removed. For extra security, the whole bottle may be placed in a resealable plastic bag, although any granules which escape should be discarded. Once opened, product from this batch should only be used for 14 days. Solvay Healthcare Limited has informed us that they will provide any additional stock required due to this issue free of charge.
For further information please contact the Solvay Healthcare Limited Medical Information Unit on 02380 467000 or e-mail medinfo.shl@solvay.com.
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)
Class 4 Drug Alert (Caution in use): Solvay Healthcare Limited - Creon Micro Pancreatin 60.36mg Gastro-resistant Granules - EL (09)A/22 
