FDA recall D-0838-2016

Product

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-04-18

Report date

2016-05-11

Termination date

2018-08-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Largo, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0838-2016