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 300microns 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. DHPC

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.

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Class 2 Medicines Recall: Ozurdex 700 micrograms intravitreal implant in applicator manufactured by Allergan Pharmaceuticals Ireland (MDR 95-08/18)

Published 5 October 2018