Company-led drug alert - Ozurdex implant recall (MDR 95-08/18)

Allergan Pharmaceuticals Ireland is further recalling batches due to the possibility that a single loose silicone particle of approximately 300 microns in diameter may become detached.

Product information

Ozurdex 700 micrograms intravitreal implant in applicator (Dexamethasone)

Company name

Allergan Pharmaceuticals Ireland

Product description

Batch number Expiry date
  • E77679 04/02/2019
    E78070 22/02/2019
    E78276 07/04/2019
    E78460 09/05/2019
    E79045 22/08/2019
    E81736 23/08/2020
    E82243 25/10/2020
    E82876 12/02/2021

Brief description of the problem

In October 2018, Allergan recalled certain batches of OZURDEX® product due to the potential for a silicone particle from the needle sleeve to be implanted into the eye during product administration (EL (18)A/16).

At the time of the initial recall, there were some unexpired batches on the UK market where additional testing had not identified the defect but it could not be ruled out. These batches were not recalled.

Since sufficient replacement stock is now available these batches (listed above) are now being recalled by Allergan as agreed.

A copy of the Dear Healthcare Professional Communication issued by Allergan on 28 February 2019 is attached below.

Company contacts for further information

Allergan Customer Services Tel: 0808 238 1500, option 1 Email: ukcustomerservices@allergan.com

Company Contact for medical information

Tel: 01628 494026

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Ozurdex 700 micrograms intravitreal implant in applicator (Dexamethasone) DHPC

Published 18 March 2019