The Drug Controller General of India has told a pharmaceutical company to recall one of its products, Ozurdex Intravitreal Implant, a steroid eye implant for macular edema, after the company admitted that a silicone particle has been detected in it.
During a routine manufacturing inspection, a silicone particle, approximately 300 microns in diameter, was observed in dispensed Ozurdex implants, a statement by the Allergan India Pvt Ltd said.
The silicone particle has been confirmed to originate from the needle sleeve.
The silicone sleeve is an intrinsic part of the Ozurdex product and the particle is not an external contaminant, it said.
Batches of Ozurdex already distributed in India are affected by this defect. Generally, most batches have 2 to 4 per cent defective units, but defect rates as high as 22 per cent have been reported, the company statement said.
"Ozurdex batches known to be affected are being recalled from the Indian market. New stocks of Ozurdex that are reliably known to be free of this defect will be made available in India and Allergan will provide an update when new stocks will be available for each market," it said.
Until unaffected product is available, clinicians are advised to consider alternative treatments.
Allergan has identified a corrective action that eliminates creation of the particle and is working quickly to implement this action prior to releasing any further product in agreement with the Irish health agency (Health Products Regulatory Authority), the statement said.
A separate communication is also being sent to hospitals providing details of the recall process, it added.
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