Hydrocodone Bitartrate and Acetaminophen Oral Solution recalled over manufacturing violations

Recall date

January 18, 2017

Source

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

Official notice title

VistaPharm, Inc. recalls Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 12 bottles…

Recall number

D-0458-2017

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

Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 12 bottles per case (NDC 66689-023-04), b) 16 fl.oz. (473 mL), 12 bottles per case (NDC 66689-023-16), c) 50 unit dose cups of 15 mL per case, (NDC No. 66689-023-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771