FDA Drug Class II — Moderate

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

Hazard

Lack of Assurance of Sterility; due to leaking vials

Products

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: M
Brand
Mylan Institutional LLC
UPC
Lot 7602281, Exp 4/16; Lot 7602283, Exp 4/16

Units Affected

11,030 cartons (55,150 vials)