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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