D-0462-2017 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
- 18,437 unit dose cups
Product Description
Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-038-50.
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
Lot No. 422800 (1Exp. 0/17), 430500 (Exp. 12/17), 424000 (Exp. 10/17), 412500 (Exp. 07/17), 405500 (Exp. 05/17), 414900 (Exp. 09/17)