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.

Recall Number: D-0466-2017

Firm: VistaPharm, Inc.

Classification: Class II

Status: Terminated

Report Date: 20170208

Initiation Date: 20170118

Termination Date: 20210826

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

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.