US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jan 18, 2017 (10 years ago)

Methadone Hydrochloride Oral Concentrate

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

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.

Recalling firm
VistaPharm, Inc.
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0466-2017

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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