Class 4 Drug Alert (Caution in use): Marlborough Pharmaceuticals Ltd - Sinepin Capsules 50mg (Doxepin Capsules 50mg) - EL (09)A/11

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Dear Healthcare Professional,

Batch Number	Expiry Date	Pack Size	First Distributed
0901001	01/2012	28 capsules per carton	25/03/2009

 

Marlborough Pharmaceuticals Ltd have informed us that packs of Sinepin 50mg from the above batch have an error in the Braille print on the front of the carton. The Braille embossed on the carton states ‘Sinepin 25mg’. This is incorrect and it should state ‘Sinepin 50mg’

The error affects only packs of 50mg capsules imprinted with batch number 0901001. All other batches are unaffected. We understand that the company has re-worked stocks of batch 0901001 which had not yet entered the supply chain. This stock will be distributed as batch number 0901001A and is not affected by this notification.

Pharmacists are asked to contact any visually impaired customers who may have received this batch to make them aware of this issue. Alternative batches of Sinepin 50mg capsules are available; therefore batch 0901001 should not be dispensed to anyone who relies on Braille for the identification of the product.

Further Information
For further information, please contact Marlborough Pharmaceuticals Ltd, tel 01672 514187, e-mail info@marlborough-pharma.co.uk

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

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)