FDA-Drug2016-05-11Class II
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
VistaPharm, Inc.
Hazard
Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.
Sold states
Nationwide
Affected count
8,901 cases
Manufactured in
7265 Ulmerton Rd, Largo, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0838-2016Don't want to check this manually?
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