D-0146-2017 Class II Terminated
FDA drug recall D-0146-2017 was initiated by VistaPharm, Inc. on Nov 9, 2016 and is designated Class II. Reason for recall: Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia. The recall status is terminated (terminated Sep 24, 2021). Affected quantity: 1497 cases.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 30, 2016
- Initiation Date
- Nov 9, 2016
- Termination Date
- Sep 24, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1497 cases
Product Description
Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039-50), Rx only, Manufactured by VistaPharm, Inc., Largo, FL 33771.
Reason for Recall
Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
Distribution Pattern
Nationwide
Code Information
Lot No. 378300, Exp 11/16
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0146-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026