FDA recall D-0421-2015

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

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2015-02-18

Report date

2015-04-01

Termination date

2017-02-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rockford, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0421-2015