FDA-Drug2017-02-08Class II

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.

VistaPharm, Inc.
Hazard

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

Sold states
Nationwide
Affected count
14,368 bottles
Manufactured in
7265 Ulmerton Rd, N/A, Largo, FL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0466-2017

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