VistaPharm, Inc. recalls Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) (NDC 66689-401-01), shrink- wrapped in 10 unit dose cups…

Recall date

April 18, 2016

Source

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

Recall number

D-0838-2016

FDA classification

Class II

Brand / firm

VistaPharm, Inc.

Sold / distributed

Nationwide

Why it was recalled

Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.

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

What was recalled

Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) (NDC 66689-401-01), shrink- wrapped in 10 unit dose cups x 5 trays per case (NDC 66689-401-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771