Allergan New Zealand has issued an urgent recall for three batches of its Ozurdex (Dexamethasone) 700 microgram Intraocular Implant. A recall has not yet been issued for Australia.
Allergan NZ said in its recall notice that during a routine manufacturing inspection a silicone particle about 300 microns in diameter had been observed in dispensed Ozurdex implants. The silicone particle was later confirmed to originate from the needle sleeve which is an intrinsic component of the applicator. Preliminary data shows several batches have units that contain a silicone particle so Allergan NZ had initiated a recall of these batches, with the knowledge of Medsafe.
Allergan ANZ’s director of medical and scientific affairs, Dr George Labib, told delegates at RANZCO’s Scientific Congress in Adelaide the problem had been fixed and that new batches would be available in the first quarter of next year.
The recall affects batches E79613 (SKU93348EZ), 9E81083 (SKU93348EZ) and E80016 (SKU93348ED).