Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.
DRUG ALERT
Class 2 medicines recallPharmacy or equivalent level recall
| 12 February 2009 | EL (09)A/04 | Our ref: MDR 11-02/09 |
Dear Healthcare Professional,
Quadrant Pharmaceuticals Limited
Clexane 40mg/0.4ml pre-filled syringe (Parallel Import)
(Enoxaparin 40mg/0.4ml pre-filled syringe)
| Batch No | Expiry date | Pack size | First distributed to wholesalers |
| 08011 | February 2011 | 10x0.4ml pre-filled syringe | 29 th May 2008 |
Quadrant Pharmaceuticals Limited is recalling the above batch of Clexane 40mg/0.4ml because it is contaminated with a low level of Over Sulphated Chondroitin Sulphate (OSCS).
A series of drug alerts were issued in 2008 related to Clexane and OSCS contamination. We understand that contamination levels in batch 08011 are not as high as those listed in EL(08)A/04 referring to parallel imports (issued on 9 May 2008). However contamination-free stocks of originator and parallel imported product have been available for several months and there is no reason or justification for any contaminated material to remain in the supply chain
Recipients are asked to quarantine any remaining stock and return it via their wholesaler for credit.
For medical information and stock return enquiries please contact Quadrant on 01204 473136
It is possible that batch 08011 may have been imported by other Parallel Importers. The batch number may have been modified by the addition of a prefix or a suffix. Please contact the DMRC on 0207 084 2574 if this batch is identified in any other livery.
Further advice will be issued to Parallel Importers within the next few days.
Recipients of this Drug Alert should bring this information to the attention of relevant contacts by copy of this letter. Primary Care Trusts are asked to bring this information to the attention of relevant clinics, General Practitioners and Community Pharmacists by copy of this letter.
Yours faithfully
Ian Holloway
MHRA DMRC Manager
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 2 Drug Alert (action within 48 hours): Quadrant Pharmaceuticals Limited - Clexane 40mg/0.4ml pre-filled syringe (Parallel Import) (Enoxaparin 40mg/0.4ml pre-filled syringe) - EL (09)A/04 
