Methadone Hydrochloride Oral Concentrate recalled over manufacturing violations

Recall date

January 18, 2017

Source

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

Official notice title

VistaPharm, Inc. recalls Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 liter (1000 mL), 4 bottles per case, Rx onl…

Recall number

D-0466-2017

FDA classification

Class II

Brand / firm

VistaPharm, Inc.

Sold / distributed

Nationwide

Why it was recalled

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

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

What was recalled

Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 liter (1000 mL), 4 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-695-79.