Class 1 Drug Alert (Action now – including out of hours): Niche Generics Ltd and Actavis UK Ltd - Oxybutynin Hydrochloride Tablets 5mg - EL(09)A/13

---

Dear Healthcare Professional,

Product distributed in both Niche and Actavis liveries

Livery	Batch No	Expiry Date	Pack Size	First Distributed
Niche	09D02	12/2011	84	16/04/2009
Niche	09D04	12/2011	84	16/04/2009
Actavis	146401	12/2011	56	05/05/2009
Actavis	146402	12/2011	56	22/05/2009

Niche Generics Ltd, the product marketing authorisation holder, are recalling all remaining stock of the above batches due to the possible inclusion of undispersed active ingredient which has the potential to result in patient overdose. The above marketing authorisation number has been used for stock distributed in Niche Generics and Actavis liveries.

We understand that the undispersed active ingredient has been found during the early stages of production and may not reach the finished tablet. Work is ongoing to obtain more information, but in the interim all remaining stock is being recalled as a precautionary measure.

Both companies have requested that patients should be contacted and supplied with replacement stock from unaffected batches.

Medical information (for both liveries)can be obtained from the Niche Medical Information Department (Dr Vineet Kacker) on 07753 606357 or vineet.kacker@apcpharma.co.uk

All unused stock of the listed batches should be quarantined and returned for credit via the original supplier. For returns and credit enquiries, please contact Niche Customer services on 01462 633816 or csuk@nichegenerics.com or Actavis Customer Services on 0800 373 573.

Recipients of this Drug Alert should bring this to the attention of relevant contacts by copy of this letter. Primary Care Trusts are asked to bring this to the attention of relevant clinics, General Practitioners and Community Pharmacists by copy of this letter.

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).