Class 4 Drug Alert (Caution in Use): Matrifen 100 micrograms/hour Transdermal Patch, Teva UK Livery - Takeda UK Limited (EL (13)A/29)

Takeda UK Limited has informed us that there is an error in the text on the pouch for batches of Matrifen 100 micrograms/hour Transdermal Patches distributed since 25 May 2013 in Teva UK livery.

Drug alert

CLASS 4 MEDICINES DEFECT INFORMATION

Caution in Use

Distribute to Pharmacy Level

12 December 2013   EL (13)A/29   Our ref:  MDR 35-09/13

Dear Healthcare Professional,

Takeda UK Limited

Matrifen 100 micrograms/hour Transdermal Patch, Teva UK Livery

(Fentanyl)

PL 16189/0018

Takeda UK Limited has informed us that there is an error in the text on the pouch for batches of Matrifen 100 micrograms/hour Transdermal Patches distributed since 25 May 2013 in Teva UK livery. The strength is expressed correctly in the heading but in the smaller body text underneath, it is expressed incorrectly, as 75 micrograms/hour. The size of the patch is also stated incorrectly. It is given as 25.2cm², whereas it is actually 33.6cm².

The text on the carton, the patch label and in the patient information leaflet is all correct.

To avoid disruption of supply, distribution of affected stock will continue for the next few weeks. Corrected stock is expected to be available during February 2014, when distribution of affected stock will cease.

For further information, please telephone Takeda medical information on 01628 537900.

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Local area teams are asked to forward this to relevant clinics, general practitioners and community pharmacists for information.

Yours faithfully

Alison Bunce

Defective Medicines Report Centre
151 Buckingham Palace Road
London
SW1W 9SZ
Telephone +44 (0)20 3080 6574

MHRA Distribution (further recipients by cascade): .

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