
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
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