D-0463-2017 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
- 7,404 unit dose cups
Product Description
Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-039-50.
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. 728300 (Exp. 11/17), 423200 (Exp. 10/17), 418400 (Exp. 09/17), 411100 (Exp. 07/17), 406500 (Exp. 06/17)