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

Recall Number: D-0421-2015

Firm: Mylan Institutional LLC

Classification: Class II

Status: Terminated

Report Date: 20150401

Initiation Date: 20150218

Termination Date: 20170223

Lack of Assurance of Sterility; due to leaking vials

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