WHO Notice of Concern (NOC) - Rabies vaccine (Lyssavac) Cadila Healthcare Limited

This is to inform that the recent GMP inspection (26 - 30 October 2015) of Cadila Healthcare Limited, Ahmedabad, Gujarat, India, as part of the WHO Prequalification Vaccine evaluation and monitoring process, noted issues that have been considered of concern.

The attached Notice of Concern (NOC) has therefore been issued to the company. The company immediately stopped production, initiated an internal investigation and initiated a voluntary recall of all the batches of Lyssavac-N (Anti-rabies Vaccine) manufactured after April 2015, from when investigation revealed the critical issue could have started. The company has also informed WHO that the suspended manufacturing activities for vaccines and biologicals at this site will only resume after acceptable CAPAs have been submitted, assessed and confirmed through an onsite inspection to have been effectively implemented.

The Prequalification Team will provide updates on any new developments on this matter.

Cadila Healthcare Limited (29 January 2016), Ahmedabad - INDIA

Source: WHO