Recall: D-0421-2015

Class II - Potentially Harmful

Class IIClassification

2015-02-18Initiated

TerminatedStatus

Mylan Institutional LLCFirm

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

Lack of Assurance of Sterility; due to leaking vials

Distribution

Nationwide and Puerto Rico

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.