D-0464-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 8, 2017
- Initiation Date
- January 18, 2017
- Termination Date
- August 26, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42,776 unit dose cups and 17,403 bottles
Product Description
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.
Reason for Recall
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Distribution Pattern
Nationwide
Code Information
a). Lot No. 427900, 426700 (Exp. 11/17), 424800, 423600 (Exp. 10/17), 420800 (09/17), 416300 (08/17), 407700, 407300 (Exp. 06/17), 405900, 403900 (Exp. 05/17) b). Lot No. 426900 (Exp. 11/17), 404700 (Exp. 05/17), 390200 (Exp. 02/17)