Mylan Institutional LLC recalls Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00) packa
Recalled April 1, 2015 · FDA recall D-0421-2015 · Mylan Institutional
Hazard
Lack of Assurance of Sterility; due to leaking vials · FDA Class II
Units
11,030 cartons (55,150 vials)
Sold at
Nationwide and Puerto Rico
Description
Lack of Assurance of Sterility; due to leaking vials
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
Manufacturer(s)
Mylan Institutional LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →