Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

Due to an incident of “foreign capsule” in the bottle, Dr.Reddy’s initiated a voluntary recall of a batch of  Tacrolimus 1mg capsules in US. A 0.5mg Tacrolimus capsule was observed in a bottle of 1mg Tacrolimus capsules, which led to the recall. The recalled batch was manufactured at Dr.Reddy’s Bachupally plant near Hyderabad. Tacrolimus capsule is a calcineurin-inhibitor immunosuppressant indicated to prevent rejection of a transplanted organ

Recall report

Leave a Comment