Medicine recall 27 February 2013

GoldenEye 0.15% w/w eye ointment – issue with seal integrity and compromised sterility assurance

Yes – this has been recalled

The problem: (Cambridge Healthcare Supplies Limited on behalf of Typharm Limited) Remaining stocks of the affected batches should be quarantined and returned to Cambridge Healthcare Supplies Limited – class 2 action within 48 hours. (EL (13)A/06)
What to do: Check the batch number on your pack against the list below. Do not stop taking a prescribed medicine without talking to your pharmacist, GP or prescriber first – they can check your supply and swap it if needed.

Source: Medicines and Healthcare products Regulatory Agency (MHRA) Official notice ↗

27 February 2013

Class 2 medicines recall

Action within 48 hours

Pharmacy, wholesaler and clinic-level recall

MDR 56-02/13

Product details

Typharm Limited

GoldenEye 0.15% w/w eye ointment

(Dibrompropamidine Isetionate)

PL 00551/0004

Alert details

Batch number: 102732
Expiry date: October 2015
Pack size: 1 x 5g
First distributed: 24 January 2013

Cambridge Healthcare Supplies Limited, distributors of GoldenEye 0.15% w/w eye ointment on behalf of Marketing Authorisation Holder, Typharm Limited are recalling all remaining stock of this batch to Pharmacy, clinic and wholesaler level, due to an issue with seal integrity and compromised sterility assurance, introduced during the filling process.

Remaining stocks of the affected batches should be quarantined and returned to Cambridge Healthcare Supplies Limited at the address below for credit.

Cambridge Healthcare Supplies Limited
Freepost RSSX-TSLG-XSET
Chestnut Drive
Wymondham
NR18 9SB

For medical information enquiries please contact Cambridge Healthcare Supplies Limited by telephone on 01953 607856 or by email on medinfo@cambridge-healthcare.co.uk

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 and to general practitioners and community pharmacists for information.

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)

Download documents

Class 2 Drug Alert (Action Within 48 Hours): Typharm Limited – GoldenEye 0.15% w/w eye ointment – Dibrompropamidine Isetionate – EL (13)A/06 (168Kb)

Updated 27 February 2013. This page summarises an official notice. Details can change – always follow the official notice.