FDA-Drug2017-02-08Class II
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.
VistaPharm, Inc.
Hazard
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Sold states
Nationwide
Affected count
42,776 unit dose cups and 17,403 bottles
Manufactured in
7265 Ulmerton Rd, N/A, Largo, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0464-2017Don't want to check this manually?
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