Haloperidol Decanoate Injection recalled over sterility concerns

Recall date

February 18, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Mylan Institutional LLC recalls Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packa…

Recall number

D-0422-2015

FDA classification

Class II

Brand / firm

Mylan Institutional LLC

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

Lack of Assurance of Sterility; due to leaking vials

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packaged in cartons of ten (NDC 67457-410-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103