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DRUG ALERT
Class 4 medicines defect informationFor distribution to physicians, pharmacists and wholesalers
| 20 August 2008 | EL(08)A/12 | Our ref: MDR 20-08/08 |
Dear Healthcare Professional,
Baxter Healthcare Ltd
Brevibloc injection 10mg/ml vials
Esmolol hydrochloride 10mg/ml
The MHRA has been informed that batches of Brevibloc vials , distributed since the start of 2008, have been distributed with an error in the Technical Leaflet (TL) document supplied in the pack. The document title paragraph incorrectly states the strength as 10mg/10ml in two places. Other text in the TL document, pack and product labelling is correct.
The error is likely to affect the majority of stock in the supply-chain and we recommend that all stock is regarded as defective in this respect.
In the meantime we wish to inform healthcare professionals of the potential for patient overdose if the incorrect TL statement is used to calculate a patient dose without reference to the vial or carton label.
Error-free packs are not likely to be supplied to the market before October 2008. Further deliveries over the next few weeks will include packs with this defect.
We understand that Brevibloc 10mg/ml Solution for Infusion (PL 00116/0352) is NOT AFFECTED and is not included within the scope of this notice.
Further Information
For medical enquiries, please telephone Baxter Healthcare Medical Information on 01635 206345.
We expect this product is mainly used in a hospital setting but, in view of the nature of this problem, have included General Practitioners, Community Pharmacists and Wholesalers in the distribution list.
Recipients of this Drug Alert are requested to bring this to the attention of relevant professionals by copy of this letter. Primary Care Trusts are asked to forward this information to relevant clinics, General Practitioners and Community Pharmacists.
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)
Class 4 Drug Alert (Caution in use):Baxter Healthcare Ltd - Brevibloc injection 10mg/ml vials - EL(08)A/12 
