DCGI asks company to recall Ozurdex Intravitreal implants

The Drug Controller General of India (DCGI) has asked 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 Private Limited 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