Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose cups of 5 mL per case (NDC No. 66689-401-50), b). 500 mL, 12 bottles per case (NDC No. 66689-403-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771.

Recall Number: D-0464-2017

Firm: VistaPharm, Inc.

Classification: Class II

Status: Terminated

Report Date: 20170208

Initiation Date: 20170118

Termination Date: 20210826

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

Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose cups of 5 mL per case (NDC No. 66689-401-50), b). 500 mL, 12 bottles per case (NDC No. 66689-403-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771.