The Medicines and Healthcare products Regulatory Agency (MHRA) issued a recall for eight batches of Ozurdex 700 micrograms intravitreal implant in applicator (Dexamethasone).
The company led-recall is taking place due to the possibility that a single loose silicone particle of approximately 300 microns in diameter may become detached.
This is the second recall in a year by Allergan Pharmaceuticals Ireland for Ozurdex products. The last recall in October, 2018 involved certain batches “due to the potential for a silicone particle from the needle sleeve to be implanted into the eye during product administration.”
MHRA clarified that during the last recall they made additional testing on some unexpired batches available in the UK. They didn’t recall these batches at the time because the tests failed to identify the defect although it wasn’t possible to rule it out the possibility.
These batches are now being recalled because sufficient replacement stock is now available.
MHRA advised pharmacists to contact Allergan for any further information.