Class 2 Medicines Recall: Ozurdex 700 micrograms intravitreal implant in applicator manufactured by Allergan Pharmaceuticals Ireland (MDR 95-08/18)
Allergan Pharmaceuticals Ireland is recalling specific 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 | Pack size | First distributed |
|---|---|---|---|
| E76937 | 15/10/2018 | 1 x 1 | 15/05/2016 |
| E77093 | 13/11/2018 | 1 x 1 | 16/05/2016 |
| E77113 | 23/11/2018 | 1 x 1 | 14/06/2016 |
| E77331 | 08/12/2018 | 1 x 1 | 18/07/2016 |
| E77512 | 15/01/2019 | 1 x 1 | 20/09/2016 |
| E78167 | 31/03/2019 | 1 x 1 | 14/12/2016 |
| E78897 | 11/08/2019 | 1 x 1 | 02/02/2017 |
| E79233 | 15/09/2019 | 1 x 1 | 04/04/2017 |
| E79272 | 28/09/2019 | 1 x 1 | 05/05/2017 |
| E79467 | 20/10/2019 | 1 x 1 | 20/07/2017 |
| E79891 | 07/12/2019 | 1 x 1 | 12/09/2017 |
| E80684 | 27/03/2020 | 1 x 1 | 12/09/2017 |
| E80824 | 10/04/2020 | 1 x 1 | 09/11/2017 |
| E81080 | 09/05/2020 | 1 x 1 | 09/01/2018 |
| E81350 | 03/07/2020 | 1 x 1 | 21/02/2018 |
| E82127 | 10/10/2020 | 1 x 1 | 13/03/2018 |
| E82509 | 04/12/2020 | 1 x 1 | 31/07/2018 |
Brief description of the problem
Allergan Pharmaceuticals Ireland is recalling the above batches due to the possibility that a single loose silicone particle of approximately 300microns in diameter may become detached from the needle sleeve during administration of the implant and may be delivered into the eye along with the implant.
Additional testing has shown that most of the above batches have an incidence of 2% to 4% of defective units but defect rates as high as 22% have been reported.
Batches on the market, on which additional testing has not identified the defect, will remain available. However defects in these batches cannot be ruled out. These batches will be recalled once sufficient defect free stock is available.
A Dear Healthcare Professional Communication (DHPC) has been issued on this matter.
Advice for healthcare professionals
Pharmacists
Please quarantine any affected stock and contact Allergan on the Customer Services contact details provided below to arrange the uplift and credit of the quarantined units.
Clinicians
Until unaffected stock is available, Clinicians are advised to consider alternative treatments if available and use Ozurdex only if no other treatment is suitable, taking each patient’s individual clinical condition into account. It is recommended that Ozurdex should only be used after a full discussion of the defect, it’s potential risks and any alternative available options with the patient.
It is anticipated that there may be patients where other alternatives are NOT available or suitable. In the scenario where the remaining batches in which the defect has not been detected are exhausted, clinicians can request access to quarantined stock on an individual patient supply basis from Allergan. Please contact Allergan Customer Services for further details using the contact information below.
See information from UK Medical Information on alternative treatments
Company contacts for further information
Medical information enquiries
Tel: 01628 494026 Email: UK_Medinfo@allergan.com
Stock enquiries
Allergan Customer Services Tel: 0808 238 1500, option 1 Email: ukcustomerservices@allergan.com
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS regional teams are asked to forward this to community pharmacists, hospital pharmacists and general practitioners for information.
Download document