Product: Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00) packaged in cartons of five (NDC 67457-409-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103
Reason for recall: Lack of Assurance of Sterility; due to leaking vials
Recall initiated: 20150218
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated