Class 2 Drug Alert (Action within 48 hours): Ranbaxy (UK) Limited - Gabapentin 100mg Capsules - EL (10)A/12

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Dear Healthcare Professional,

Batch number	Expiry date	Pack size	First distributed
2037862	May 2011	1x100	10 Sep 2009

Ranbaxy (UK) Limited is recalling all unused stock of the above batch because the patient information leaflet (PIL) has not been updated to include safety warnings initiated by the European Medicines Agency. The missing text should be positioned under the heading ‘Take special care with’ and states the following:

‘A small number of people being treated with anti-epileptics such as Gabapentin have had thoughts of harming and killing themselves. If at any time you have these thoughts, immediately contact your doctor’

The PIL in subsequent batches of the product has been updated.

Pharmacists are asked to quarantine all remaining stock of the above batch and return it to the wholesaler from which it was purchased.

For any stock enquiries please contact Ranbaxy (UK) Limited on 0208 742 5299. For medical information enquiries, please contact Ranbaxy (UK) limited on 0208 742 5292.

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)